No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 17290109154319 | 15072-000-0007 | 15072-000-0007 | MRZ | Accessories, Pump, Infusion | Sapphire Power Supply | ||
2 | 17290109159277 | 12003-000-0069 | 12003-000-0069 | FPA | Set, Administration, Intravascular | 2 | AP240-01 MICROBORE WITH NON-VENTED SPIKE,1.2 FILTER AND BACK CHECK VALVE | |
3 | 17290109154630 | 12003-000-0023 | 12003-000-0023 | FPA | Set, Administration, Intravascular | 2 | AP423-01 MICROBORE WITH VENTED NON-VENTED SPIKE AND A BACK CHECK VALVE | |
4 | 17290109154227 | 15171-000-0004 | 15171-000-0004 | MRZ | Accessories, Pump, Infusion | Sapphire Multi-Pump Mounting System compatible with IPS | ||
5 | 17290109154197 | 15042-000-0010 | 15042-000-0010 | MRZ | Accessories, Pump, Infusion | Mini Cradle - US | ||
6 | 17290109153954 | 15061-131-0004 | 15061-131-0004 | MRZ | Accessories, Pump, Infusion | PCA Lockbox 100 ml | ||
7 | 17290109153121 | 12003-000-0069 | 12003-000-0069 | FPA | Set, Administration, Intravascular | 2 | AP240-01- MICROBORE INFUSION SET WITH NON-VENTED SPIKE, FX ADMINISTRATION CASSET | |
8 | 17290109150540 | 12000-000-0030 | 12000-000-0030 | FPA | Set, Administration, Intravascular | 2 | AP434-01 INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER | |
9 | 17290109150403 | 12003-000-0028 | 12003-000-0028 | FPA | Set, Administration, Intravascular | 2 | AP232-01 - MICROBORE INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, BACK CHEC | |
10 | 17290109150380 | 12004-000-0012 | 12004-000-0012 | FPA | Set, Administration, Intravascular | 2 | AP224-01 MICROBORE YELLOW MARKED WITH VENTEDNON-VENTED SPIKE AND 0.2μ FILTER | |
11 | 17290109150328 | 12006-000-0003 | 12006-000-0003 | FPA | Set, Administration, Intravascular | 2 | AP133-01 BLOOD SET WITH 2 NON-VENTED SPIKES, 200μ FILTER AND NEEDLELESS Y- | |
12 | 17290109159307 | 12004-000-0002 | 12004-000-0002 | FPA | Set, Administration, Intravascular | 2 | AP214-01 - MICROBORE YELLOW MARKED WITH VENTED/NON VENTED SPIKE AND 0.2 FILTER | |
13 | 17290109154579 | 12003-000-0033 | 12003-000-0033 | FPA | Set, Administration, Intravascular | 2 | AP223-01- MICROBORE WITH NON-VENTED SPIKE, BACK CHECK VALVE, FILTER AND NEE | |
14 | 17290109154081 | 17000-020-0010 | 17000-020-0010 | MRZ | Accessories, Pump, Infusion | Multi-Pump Mounting System Compatible with IPS- B Kit | ||
15 | 17290109153930 | 17000-020-0008 | 17000-020-0008 | MRZ | Accessories, Pump, Infusion | Sapphire Multi-Pump Mounting System Power Supply – US | ||
16 | 17290109153893 | 15043-000-0005 | 15043-000-0005 | MRZ | Accessories, Pump, Infusion | Splitter - US | ||
17 | 17290109153886 | 15072-000-0008 | 15072-000-0008 | MRZ | Accessories, Pump, Infusion | Sapphire power supply-US (interchangeble heads) | ||
18 | 17290109153183 | 12003-000-0011 | 12003-000-0011 | FPA | Set, Administration, Intravascular | 2 | AP213-01-MICROBORE INFUSION SET WITH NON-VENTED SPIKE, SLIDE CLAMP, ADMINISTRATI | |
19 | 17290109153107 | 12003-000-0070 | 12003-000-0070 | FPA | Set, Administration, Intravascular | 2 | AP204-01- MICROBORE INFUSION SET WITH NON-VENTED SPIKE, FX ADMINISTRATION CASSET | |
20 | 17290109153091 | 12003-000-0012 | 12003-000-0012 | FPA | Set, Administration, Intravascular | 2 | AP416-01- MICROBORE INFUSION SET WITH FEMALE LUER LOCK, FX ADMINISTRATIO | |
21 | 17290109150533 | 12000-000-0029 | 12000-000-0029 | FPA | Set, Administration, Intravascular | 2 | AP433-01 INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, NEEDLELESS Y-SIT | |
22 | 17290109150441 | 12003-000-0020 | 12003-000-0020 | FPA | Set, Administration, Intravascular | 2 | AP403-01 MICROBORE WITH NON-VENTED SPIKE | |
23 | 17290109150427 | 12007-000-0005 | 12007-000-0005 | FPA | Set, Administration, Intravascular | 2 | AP331-01 - NON PVC UV RESISTANT MICROBORE WITH VENTED/NON-VENTED SPIKE | |
24 | 17290109150205 | 15072-000-0010 | 15072-000-0010 | MRZ | Accessories, Pump, Infusion | 2 | Integrated Power Supply US | |
25 | 17290109159215 | 12005-000-0003 | 12005-000-0003 | FPA | Set, Administration, Intravascular | AP409-01 - PRIMARY INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, BACK CHECK | ||
26 | 17290109154272 | 17000-031-0035 | 17000-031-0035 | FRN | Pump, Infusion | Sapphire Epidural Infusion Pump Kit – US | ||
27 | 17290109153190 | 12003-000-0078 | 12003-000-0078 | FPA | Set, Administration, Intravascular | 2 | AP411-01- MICROBORE INFUSION SET WITH VENTED/NON-VENTED SPIKE, SLIDE CLAMP, NEED | |
28 | 17290109153060 | 12005-000-0003 | PFA | Non-Invasive Central Venous Manometer | 2 | AP409-01 PRIMARY INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, BACK CHECK VA | ||
29 | 17290109153046 | 12003-000-0013 | 12003-000-0013 | FPA | Set, Administration, Intravascular | AP403-01 - MICROBORE WITH VENTED/NON-VENTED SPIKE | ||
30 | 17290109150472 | 12004-000-0013 | 12004-000-0013 | FPA | Set, Administration, Intravascular | 2 | AP422-01 MICROBORE YELLOW MARKED WITH NON-VENTED SPIKE | |
31 | 17290109150373 | 12003-000-0037 | 12003-000-0037 | FPA | Set, Administration, Intravascular | 2 | AP223-01 MICROBORE WITH NON-VENTED SPIKE, BACK CHECK VALVE, 0.2μ FILTER AND | |
32 | 17290109150359 | 12004-000-0007 | 12004-000-0007 | FPA | Set, Administration, Intravascular | 2 | AP214-01 MICROBORE YELLOW MARKED WITH VENTED/NON-VENTED SPIKE AND 0.2μ FILTER | |
33 | 17290109150342 | 12003-000-0019 | 12003-000-0019 | FPA | Set, Administration, Intravascular | 2 | AP213-01 MICROBORE WITH NON-VENTED SPIKE, 0.2μm FILTER AND NEEDLELESS Y-SITE | |
34 | 17290109150021 | 15061-131-0004 | 15061-131-0004 | MRZ | Accessories, Pump, Infusion | 2 | PCA Lockbox 100 mL | |
35 | 17290109159284 | 12000-000-0022 | 12000-000-0022 | FPA | Set, Administration, Intravascular | 2 | AP206-01 INFUSION SET WITH NON-VENTED SPIKE, 1.2 FILTER AND NEEDELESS Y-SITE | |
36 | 17290109159239 | 12003-000-0023 | 12003-000-0023 | FPA | Set, Administration, Intravascular | 2 | AP423- MICROBORE WITH NON-VENTED SPIKE AND A BACK CHECK VALVE | |
37 | 17290109154203 | 15171-010-0005 | 15171-010-0005 | MRZ | Accessories, Pump, Infusion | Multi-Pump Mounting System Compatible with IPS | ||
38 | 17290109153978 | 15071-000-0005 | 15071-000-0005 | MRZ | Accessories, Pump, Infusion | Bolus handle - US | ||
39 | 17290109150526 | 12000-000-0028 | 12000-000-0028 | FPA | Set, Administration, Intravascular | 2 | AP432-01 INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER,BACK CHECK VALVE, | |
40 | 17290109150519 | 12000-000-0027 | 12000-000-0027 | FPA | Set, Administration, Intravascular | 2 | AP431-01 INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER,BACK CHECK VALVE, | |
41 | 17290109150434 | 12004-000-0008 | 12004-000-0008 | FPA | Set, Administration, Intravascular | 2 | AP402-01 MICROBORE YELLOW MARKED WITH NON-VENTED SPIKE | |
42 | 17290109150397 | 12003-000-0027 | 12003-000-0027 | FPA | Set, Administration, Intravascular | 2 | AP231-01 - INFUSION SET WITH VENTED/NON-VENTED DRIP CHAMBER, BACK CHECK VALVE, 2 | |
43 | 17290109150366 | 12003-000-0036 | 12003-000-0036 | FPA | Set, Administration, Intravascular | 2 | AP220-01 MICROBORE WITH NON-VENTED SPIKE, BACK CHECK VALVE AND 1.2μ | |
44 | 17290109150175 | 17000-020-0008 | 17000-020-0008 | MRZ | Accessories, Pump, Infusion | 2 | Multi-Pump Mounting System kit single pack for US | |
45 | 17290109150137 | 17000-031-0027 | 17000-031-0027 | FRN | Pump, Infusion | 2 | Sapphire Epidural Infusion Kit-US | |
46 | 17290109150120 | 17000-028-0062 | 17000-028-0062 | FRN | Pump, Infusion | 2 | Sapphire M.T. with Bolus and Splitter Kit -US | |
47 | 17290109150090 | 17000-020-0008 | 17000-020-0008 | MRZ | Accessories, Pump, Infusion | 2 | Multi-Pump Mounting System kit single pack for US | |
48 | 17290109159314 | 12000-000-0045 | FPA | Set, Administration, Intravascular | 2 | AP504- UV RESISTANT INFUSION SET WITH VENTED/NONVENTED DRIP CHAMBER AND NEEDLELE | ||
49 | 17290109159260 | 12003-000-0070 | 12003-000-0070 | FPA | Set, Administration, Intravascular | 2 | AP204 MICROBORE WITH NON-VENTED SPIKE, 0.2 FILTER AND BACK CHECK VALVE | |
50 | 17290109159253 | 12006-000-0010 | 12006-000-0010 | FPA | Set, Administration, Intravascular | 2 | AP133-01 - BLOOD SET WITH 2 NON-VENTED SPIKES, 200 FILTER AND NEEDLESS Y-SITE |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 10610586043628 | 2130 | 21-2130-51 | CADD | SMITHS MEDICAL MD, INC. | |
2 | 10610586043611 | 67-2450-0105-51 | Medfusion | SMITHS MEDICAL MD, INC. | ||
3 | 10610586043581 | 4000-0105-249 | Medfusion | SMITHS MEDICAL MD, INC. | ||
4 | 10610586043574 | 4000-0105-78 | Medfusion | SMITHS MEDICAL MD, INC. | ||
5 | 10610586043567 | 4000-0105-51 | Medfusion | SMITHS MEDICAL MD, INC. | ||
6 | 10610586043307 | 3500-0600-78 | Medfusion | SMITHS MEDICAL ASD, INC. | ||
7 | 10610586043291 | 3500-0600-51 | Medfusion | SMITHS MEDICAL MD, INC. | ||
8 | 10610586043017 | 3500-0600-82 | Medfusion | SMITHS MEDICAL MD, INC. | ||
9 | 10610586042874 | 67-2454-0300-51 | Medfusion | SMITHS MEDICAL MD, INC. | ||
10 | 10610586042867 | 67-2449-0300-51 | Medfusion | SMITHS MEDICAL MD, INC. | ||
11 | 10610586042799 | 67-2460-0003-51 | Medfusion | SMITHS MEDICAL MD, INC. | ||
12 | 10610586042423 | 67-2477-0600-01 | Medfusion | SMITHS MEDICAL MD, INC. | ||
13 | 10610586041549 | 67-2466-0200-51 | Medfusion | SMITHS MEDICAL MD, INC. | ||
14 | 10610586041525 | 22-4095-0200-51 | Medfusion | SMITHS MEDICAL MD, INC. | ||
15 | 10610586041259 | 3500-0600-00 | Medfusion | SMITHS MEDICAL MD, INC. | ||
16 | 10610586041242 | 3500-0600-01 | Medfusion | SMITHS MEDICAL MD, INC. | ||
17 | 10610586040962 | 22-4075-0300-51 | Medfusion | SMITHS MEDICAL MD, INC. | ||
18 | 10610586040818 | 4000-0101-51 | Medfusion | SMITHS MEDICAL MD, INC. | ||
19 | 10610586040658 | 67-2467-0101-51 | Medfusion | SMITHS MEDICAL MD, INC. | ||
20 | 10610586040108 | 22-4097-0101-51 | Medfusion | SMITHS MEDICAL MD, INC. | ||
21 | 10610586040092 | 22-4095-0101-51 | Medfusion | SMITHS MEDICAL MD, INC. | ||
22 | 10610586039812 | 22-4075-0201-51 | Medfusion | SMITHS MEDICAL MD, INC. | ||
23 | 10610586033803 | 21-2194-249 | CADD | SMITHS MEDICAL MD, INC. | ||
24 | 10610586033797 | 21-2194-51 | CADD | SMITHS MEDICAL MD, INC. | ||
25 | 10610586033780 | 21-2193-249 | CADD | SMITHS MEDICAL MD, INC. | ||
26 | 10610586031489 | 22-1000-51 | Medfusion | SMITHS MEDICAL MD, INC. | ||
27 | 08809220581045 | ⅡS Kits | DANA Diabecare ⅡS is external programmable syringe infusion pump used for the su DANA Diabecare ⅡS is external programmable syringe infusion pump used for the subcutaneous delivery of insulin for the treatment of diabetes mellitus. | DANA Diabecare | SOOIL DEVELOPMENT CO.,LTD | |
28 | 08809220580765 | DANA 3cc Syringe | DANA 3cc Syringe is an insulin reservoir for using insulin pump. It is installed DANA 3cc Syringe is an insulin reservoir for using insulin pump. It is installed into the SOOIL's insulin pump and connected to an infusion set in order to deliver insulin to the patients. | DANA 3cc Syringe | SOOIL DEVELOPMENT CO.,LTD | |
29 | G002RG30 | RG3 | RG3 | SHIFENG MEDICAL TECHNOLOGY CO.,LTD. | ||
30 | 04086000856720 | Z078135 | Z078135 | Agilia Link 8 is an accessory to Agilia Infusion System as the stacking rack sys Agilia Link 8 is an accessory to Agilia Infusion System as the stacking rack system intended to power and organize eight Agilia infusion pumps at the patient bedside. The Agilia Infusion System includes the Agilia Infusion Pump, which is a programmable electronic medical system dedicated to administering a pre-determined volume of an infusion product at a programmed rate, in combination with disposables and optional accessories. | AGILIA LINK 8 US | FRESENIUS KABI AG |
31 | 04086000856713 | Z076135 | Z076135 | Agilia Link 6 is an accessory to Agilia Infusion System as the stacking rack sys Agilia Link 6 is an accessory to Agilia Infusion System as the stacking rack system intended to power and organize six Agilia infusion pumps at the patient bedside. The Agilia Infusion System includes the Agilia Infusion Pump, which is a programmable electronic medical system dedicated to administering a pre-determined volume of an infusion product at a programmed rate, in combination with disposables and optional accessories. | AGILIA LINK 6 US | FRESENIUS KABI AG |
32 | 04086000856669 | Z074135 | Z074135 | Agilia Link 4 is an accessory to Agilia Infusion System as the stacking rack sys Agilia Link 4 is an accessory to Agilia Infusion System as the stacking rack system intended to power and organize four Agilia infusion pumps at the patient bedside. The Agilia Infusion System includes the Agilia Infusion Pump, which is a programmable electronic medical system dedicated to administering a pre-determined volume of an infusion product at a programmed rate, in combination with disposables and optional accessories. | AGILIA LINK 4 US | FRESENIUS KABI AG |
33 | 04086000852074 | Z073550 | Z073550 | The Agilia USB Cable is intended to connect the Agilia pumps from Fresenius Kabi The Agilia USB Cable is intended to connect the Agilia pumps from Fresenius Kabi to a computer with Fresenius Kabi maintenance or DERS software. | AGILIA USB CABLE US | FRESENIUS KABI AG |
34 | 04052682058912 | Z073607 | Z073607 | Agilia Duo is an accessory to Agilia Infusion System as the stacking rack system Agilia Duo is an accessory to Agilia Infusion System as the stacking rack system intended to power and organize two Agilia infusion pumps at the patient bedside. The Agilia Infusion System includes the Agilia Infusion Pump, which is a programmable electronic medical system dedicated to administering a pre-determined volume of an infusion product at a programmed rate, in combination with disposables and optional accessories. | AGILIA DUO US | FRESENIUS KABI AG |
35 | 04046963418373 | 8713152 | 8713152 | SpaceStation MRI | SPACE | B. BRAUN MEDICAL INC. |
36 | 04046955083077 | 8713330 | 8713330 | SPACE LOCKBOX FOR PERFUSOR SPACE PUMPS | Perfusor® | B. BRAUN MEDICAL INC. |
37 | 00860008635402 | B | 10013795 EBS | Elite Biomedical Solutions Dose Request Cord is a replacement for the BD Alaris Elite Biomedical Solutions Dose Request Cord is a replacement for the BD Alaris PCA Pump Model 8120 syringe infusion pump. Elite Biomedical Solutions does not manufacture the pump. The Dose Request Cord is an accessory for the pump and is available as a replacement part. The Dose Request Cord contains a handpiece with integral cable which plugs into the mating connector on the BD Alaris PCA Pump to allow the patient to request medication within the parameters entered into the syringe/infusion pump by the healthcare provider and the designed limits on the pumps.The Elite Biomedical Solutions Dose Request Cord has the same type of construction and technological characteristics as the predicate device, which is also a replacement bolus cable. Both the subject and predicate device are equivalent to the accessories supplied with the original pump. The Dose Request Cords are passive devices that contain no powered electronic components. They are powered by the mating equipment using low voltages to detect changes in the state of the push button. Shielding and insulation of these devices is substantially equivalent to the predicate device. | Elite Biomedical Solutions | ELITE BIOMEDICAL SOLUTIONS LLC |
38 | 00815277022880 | TA-UOM | Thermal Angel Ultra Operations Module | Curaplex | BOUND TREE MEDICAL, LLC | |
39 | 00815277022873 | TA-UEP | Thermal Angel Ultra Emergency Pack, incl 2 IV Fluid Warmers, 2 Ext Sets, Battery Thermal Angel Ultra Emergency Pack, incl 2 IV Fluid Warmers, 2 Ext Sets, Battery, Charger, Cable | Curaplex | BOUND TREE MEDICAL, LLC | |
40 | 00815277022866 | TA-SEP | Thermal Angel Standard Emergency Pack, incl 4 IV Fluid Warmers, 4 Ext Sets, Batt Thermal Angel Standard Emergency Pack, incl 4 IV Fluid Warmers, 4 Ext Sets, Battery, Charger, Cable | Curaplex | BOUND TREE MEDICAL, LLC | |
41 | 00815277022859 | TA-DEP | Thermal Angel Disposable Emergency Pack Reload Kit, incl 4 IV Fluid Warmers, 4 Ext Sets | Curaplex | BOUND TREE MEDICAL, LLC | |
42 | 00815277022842 | TA-200DEMOKIT | KIT, TA-200 BLOOD WARMER NON-STERILE DEMO | Curaplex | BOUND TREE MEDICAL, LLC | |
43 | 00610586018636 | 21-5814-01 | CADD | SMITHS MEDICAL MD, INC. | ||
44 | 00365702508101 | 06604765001 | 06604765001 | ACCU-CHEK 360 INSULIN PUMP CONFIG SW US | ACCU-CHEK 360 | ROCHE DIAGNOSTICS OPERATIONS, INC. |
45 | B553WELLDOCRX120 | v1.2 | Welldoc Diabetes Rx is indicated for use by healthcare providers (HCPs) and thei Welldoc Diabetes Rx is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Welldoc Diabetes Rx is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes Rx analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes Rx provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. Welldoc Diabetes Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of bolus insulin for a given amount of carbohydrates and/or blood glucose value.Welldoc Diabetes Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.Welldoc also includes other functions that are designed to maintain, encourage a healthy lifestyle or help users manage their disease or condition without providing specific treatment or treatment suggestions. | Welldoc | WELLDOC, INC. | |
46 | B553WELLDOCRX110 | v1.1 | Welldoc Diabetes Rx is indicated for use by healthcare providers (HCPs) and thei Welldoc Diabetes Rx is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Welldoc Diabetes Rx is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes Rx analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes Rx provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. Welldoc Diabetes Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of bolus insulin for a given amount of carbohydrates and/or blood glucose value.Welldoc Diabetes Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.Welldoc also includes other functions that are designed to maintain, encourage a healthy lifestyle or help users manage their disease or condition without providing specific treatment or treatment suggestions. | Welldoc Rx | WELLDOC, INC. | |
47 | B553WELLDOCRX100 | v1.0 | Welldoc Diabetes Rx is indicated for use by healthcare providers (HCPs) and thei Welldoc Diabetes Rx is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Welldoc Diabetes Rx is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes Rx analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes Rx provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. Welldoc Diabetes Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of bolus insulin for a given amount of carbohydrates and/or blood glucose value.Welldoc Diabetes Rx is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.Welldoc also includes other functions that are designed to maintain, encourage a healthy lifestyle or help users manage their disease or condition without providing specific treatment or treatment suggestions. | Welldoc Rx | WELLDOC, INC. | |
48 | B553WELLDOC120 | v1.2 | Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their p Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Welldoc Diabetes is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. Welldoc Diabetes is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.Welldoc also includes other functions that are designed to maintain, encourage a healthy lifestyle or help users manage their disease or condition without providing specific treatment or treatment suggestions. | Welldoc | WELLDOC, INC. | |
49 | B553WELLDOC110 | v1.1 | Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their p Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Welldoc Diabetes is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. Welldoc Diabetes is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.Welldoc also includes other functions that are designed to maintain, encourage a healthy lifestyle or help users manage their disease or condition without providing specific treatment or treatment suggestions. | Welldoc | WELLDOC, INC. | |
50 | B553WELLDOC100 | v1.0 | Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their p Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. Welldoc Diabetes is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. Welldoc Diabetes is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.Welldoc also includes other functions that are designed to maintain, encourage a healthy lifestyle or help users manage their disease or condition without providing specific treatment or treatment suggestions. | Welldoc | WELLDOC, INC. |