No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00801741124419 | CK000212B | CK000212B | Catheter Placement Kit | LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days | 2 | Per-Q-Cath |
2 | 00801741100109 | CK000507 | CK000507 | Catheter Placement Kit | LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days | 2 | Poly Per-Q-Cath |
3 | 00801741098215 | 0619190 | 0619190 | Hickman TriFusion 12F with Intermediate Tray | LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days | 2 | Hickman Trifusion Catheter |
4 | 00801741096211 | CK000402 | CK000402 | Catheter Placement Kit | LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days | 2 | Poly Per-Q-Cath |
5 | 00801741096204 | CK000401 | CK000401 | Catheter Placement Kit | LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days | 2 | Poly Per-Q-Cath |
6 | 00801741095962 | CK000282A | CK000282A | Catheter Placement Kit | LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days | 2 | Poly Per-Q-Cath |
7 | 00801741095931 | CK000212A | CK000212A | Catheter Placement Kit | LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days | 2 | Poly Per-Q-Cath |
8 | 00801741095863 | CK000087A | CK000087A | Catheter Placement Kit | LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days | 2 | Per-Q-Cath |
9 | 00801741127694 | CK000641 | CK000641 | Catheter Placement Kit | LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days | 2 | Per-Q-Cath |
10 | 00801741124402 | CK000113B | CK000113B | Catheter Placement Kit | LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days | 2 | Per-Q-Cath |
11 | 00801741121616 | CK000496A | CK000496A | Catheter Placement Kit | LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days | 2 | Per-Q-Cath |
12 | 00801741111488 | CP00002 | CP00002 | PowerPort isp Implantable Port | LJT | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR | 2 | PowerPort isp Implantable Port |
13 | 00801741111471 | CP00001 | CP00001 | PowerPort isp Implantable Port | LJT | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR | 2 | PowerPort isp Implantable Port |
14 | 00801741110856 | CK000583 | CK000583 | Catheter Placement Kit | LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days | 2 | Per-Q-Cath |
15 | 00801741107429 | CK000533 | CK000533 | Catheter Placement Kit | LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days | 2 | Per-Q-Cath |
16 | 00801741104329 | CK000480 | CK000480 | Catheter Placement Kit | LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days | 2 | Per-Q-Cath |
17 | 00801741104312 | CK000479 | CK000479 | Catheter Placement Kit | LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days | 2 | Per-Q-Cath |
18 | 00801741104305 | CK000478 | CK000478 | Catheter Placement Kit | LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days | 2 | Per-Q-Cath |
19 | 00801741105098 | CK000532 | CK000532 | Catheter Placement Kit | LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days | 2 | Per-Q-Cath |
20 | 00801741104343 | CK000482 | CK000482 | Catheter Placement Kit | LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days | 2 | Per-Q-Cath |
21 | 00801741104336 | CK000481 | CK000481 | Catheter Placement Kit | LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days | 2 | Per-Q-Cath |
22 | 00801741101212 | CK000088A | CK000088A | Catheter Placement Kit | LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days | 2 | Per-Q-Cath |
23 | 00801741101069 | CP00003 | CP00003 | PowerPort isp Implantable Port | LJT | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR | 2 | PowerPort isp Implantable Port |
24 | 00801741100277 | CK000496 | CK000496 | Catheter Placement Kit | LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days | 2 | Poly Per-Q-Cath |
25 | 00801741100215 | CK000492 | CK000492 | Catheter Placement Kit | LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days | 2 | Poly Per-Q-Cath |
26 | 00801741100154 | 5605200G | 5605200G | Power-Trialysis Short-Term Straight Dialysis Catheter Full Procedure Tray | NIE | CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED | 2 | Power-Trialysis |
27 | 00801741085475 | 5688000 | 5688000 | 8 in. Malleable Tunneler | MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE | Tunneler | |
28 | 00801741087110 | 1274108D | 1274108D | PowerPICC SV Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet Maxi PowerPICC SV Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet Maximal Barrier Kit, 4F Dual-Lumen 55cm | LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days | 2 | PowerPICC SV Catheter |
29 | 00801741087103 | 1173108D | 1173108D | PowerPICC SV Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet Maxi PowerPICC SV Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet Maximal Barrier Kit, 3F Single-Lumen 45cm | LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days | 2 | PowerPICC SV Catheter |
30 | 00801741086915 | 1274118 | 1274118 | PowerPICC SV Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet Basi PowerPICC SV Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet Basic Kit, 4F Dual-Lumen 55cm | LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days | 2 | PowerPICC SV Catheter |
31 | 00801741086908 | 1274108 | 1274108 | PowerPICC SV Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet Full PowerPICC SV Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet Full Kit, 4F Dual-Lumen 55cm | LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days | 2 | PowerPICC SV Catheter |
32 | 00801741086892 | 1173118 | 1173118 | PowerPICC SV Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet Basi PowerPICC SV Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet Basic Kit, 3F Single-Lumen 45cm | LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days | 2 | PowerPICC SV Catheter |
33 | 00801741086885 | 1173108 | 1173108 | PowerPICC SV Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet Full PowerPICC SV Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet Full Kit, 3F Single-Lumen 45cm | LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days | 2 | PowerPICC SV Catheter |
34 | 00801741085444 | 5583700 | 5583700 | VC GUIDEWIRE J-TIP 70CM | DQX | WIRE, GUIDE, CATHETER | 2 | J Guidewire |
35 | 00801741085420 | 0602790 | 0602790 | Extension Set 8 inch with y-site | FMI | Needle, hypodermic, single lumen | 2 | Extension Set |
36 | 00801741083051 | VADC2 | VADC2 | StatLock Arterial Plus Crescent | FPA | Set, administration, intravascular | Statlock Arterial | |
37 | 00801741083044 | VADC | VADC | StatLock Arterial Crescent | FPA | Set, administration, intravascular | 2 | Statlock Arterial |
38 | 00801741081101 | 000645 | 000645 | PEG Kit | KNT | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | Bard Guidewire PEG System | |
39 | 00801741080869 | 000268 | 000268 | Continous Feeding Tube | KGC | TUBE, GASTRO-ENTEROSTOMY | Bard Button Device Continuous Feeding Tube with 90 degree Adapter | |
40 | 00801741075261 | 7812400 | 7812400 | Groshong Replacement Connector | LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days | 2 | Groshong NXT ClearVue |
41 | 00801741223983 | CK001031 | CK001031 | Catheter Placement Kit | LJS | Catheter, intravascular, therapeutic, long-term greater than 30 days | 2 | PowerPICC Provena SOLO |
42 | 00801741045134 | 5584180 | 5584180 | Introducer Needle 18 ga | DYB | INTRODUCER, CATHETER | 2 | Introducer Needle |
43 | 00801741041822 | S03421-275W | S03421-275W | SecLoc,INTRO 21x2.75 WSF | DYB | INTRODUCER, CATHETER | Introducer Needle | |
44 | 00801741041815 | S03421-275 | S03421-275 | SecLc,INTR 21Gx2.75 ST | DYB | INTRODUCER, CATHETER | Introducer Needle | |
45 | 00801741041808 | S03421-200W | S03421-200W | SecLoc, INTRO 21Gx2 | DYB | INTRODUCER, CATHETER | 2 | Introducer Needle |
46 | 00801741041792 | S03421-200 | S03421-200 | SecLoc, INTRO 21Gx2 | DYB | INTRODUCER, CATHETER | Introducer Needle | |
47 | 00801741041747 | S03418-275W | S03418-275W | SecLoc, INTRO18Gx2.75 | DYB | INTRODUCER, CATHETER | Introducer Needle | |
48 | 00801741041730 | S03418-275 | S03418-275 | SecLoc,INTRO 18Gx2.75ST | DYB | INTRODUCER, CATHETER | 2 | Introducer Needle |
49 | 00801741041723 | S03021-275W | S03021-275W | SecLoc,INTRO 21Gx2.75 | DYB | INTRODUCER, CATHETER | 2 | Introducer Needle |
50 | 00801741041716 | S03021-275 | S03021-275 | SecLoc,INTRO 21Gx2.75 | DYB | INTRODUCER, CATHETER | Introducer Needle |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 07350025911212 | 14214 | Vitrolife Sterile Transmission Gel | Vitrolife | NEXT MEDICAL PRODUCTS, LLC | |
2 | 07350025911205 | 14213 | Vitrolife Ultrasound Transmission Gel | Vitrolife | NEXT MEDICAL PRODUCTS, LLC | |
3 | 07350010100027 | 2 | Software for cardiac image analysis. | Segment CMR | MEDVISO AB | |
4 | 07350010100010 | 2 | Software for medical image analysis. | Segment | MEDVISO AB | |
5 | 07350002336021 | 02 | 602 | PYLARIFY AI is intended to be used by healthcare professionals and researchers f PYLARIFY AI is intended to be used by healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. The system is intended to be used with images acquired using nuclear medicine (NM) imaging, using PSMA PET/CT. The device provides general Picture Archiving and Communications System (PACS) tools as well as a clinical application for oncology including marking of regions of interest and quantitative analysis. | PYLARIFY AI | EXINI DIAGNOSTICS AB |
6 | 07350002336014 | 01 | 601 | PYLARIFY AI is a software only medical device that provides quantitative assessm PYLARIFY AI is a software only medical device that provides quantitative assessments of standardized uptake values (SUVs) for patients that are subject to examination by nuclear medicine (NM) imaging, using PSMA PET/CT, within the clinical application of oncology. The device performs by automatic organ and bone segmentation and lesions, selected by the user, will automatically be calculated into a lesion index (LI) and intensity-weighted total lesion volume (ITLV). The user of this product is typically a health-care professional using the software to review patient images and analyze results. | PYLARIFY AI | EXINI DIAGNOSTICS AB |
7 | 07350002335017 | 01 | 501 | aPROMISE is a softwareonly medical device that provides quantitative assessments aPROMISE is a softwareonly medical device that provides quantitative assessments of standardized uptake values (SUVs) for patients that are subject to examination by nuclear medicine (NM) imaging within the clinical application of oncology. The device performs by automatic organ and bone segmentation and lesions, selected by the user, will automatically be calculated into a lesion index (LI) and intensityweighted total lesion volume (ITLV). The user of this product is typically a health-care professional using the software to review patient images and analyze results. | aPROMISE | EXINI DIAGNOSTICS AB |
8 | 07350002332030 | 03 | 203 | The aBSI is a software-only medical device that provides a fully quantitative as The aBSI is a software-only medical device that provides a fully quantitative assessment of a patient’s skeletal disease on a bone scan, as the fraction of the total skeleton weight. The user of this product is typically a health-care professional using the software to view the patient images and analysis results. | aBSI | EXINI DIAGNOSTICS AB |
9 | 07350002331033 | 3 | 103 | EXINI is intended to be used by trained health-care professionals and researcher EXINI is intended to be used by trained health-care professionals and researchers for acceptance, transfer,storage, image display, manipulation, quantification and reporting of digital medical images. The system isintended to be used with images acquired using nuclear imaging (NM) and computed tomography (CT). Thesoftware provides general Picture Archiving and Communications System (PACS) tools and a clinical applicationfor oncology including lesion marking and analysis. | EXINI | EXINI DIAGNOSTICS AB |
10 | 07340201500040 | AATMA | AATMA | ELEKTA SOLUTIONS AB | ||
11 | 07332747199802 | 3.2_L | 300851 | DTX Studio Clinic 3.2 for Win 64-bit limited | DTX Studio™ Clinic | NOBEL BIOCARE AB |
12 | 07332747199796 | 3.2_L | 300851 | DTX Studio Clinic 3.2 for Mac limited | DTX Studio™ Clinic | NOBEL BIOCARE AB |
13 | 07332747197525 | 2.4 | 300011 | IPS CaseDesigner 2.4 for Windows 64-bit | IPS CaseDesigner® | NOBEL BIOCARE AB |
14 | 07332747197518 | 2.4 | 300011 | IPS CaseDesigner 2.4 for MAC | IPS CaseDesigner® | NOBEL BIOCARE AB |
15 | 07332747196344 | 3.1 | 300851 | DTX Studio Clinic 3.1 for Mac | DTX Studio™ Clinic | NOBEL BIOCARE AB |
16 | 07332747196320 | 3.1 | 300851 | DTX Studio Clinic 3.1 for Win 64-bit | DTX Studio™ Clinic | NOBEL BIOCARE AB |
17 | 07332747188097 | 2.5 | 300851 | DTX Studio Clinic 2.5 for Mac | DTX Studio™ Clinic | NOBEL BIOCARE AB |
18 | 07332747188080 | 2.5 | 300851 | DTX Studio Clinic 2.5 for Win 64-bit | DTX Studio™ Clinic | NOBEL BIOCARE AB |
19 | 07332747187045 | 2.4 | 300851 | DTX Studio Clinic 2.4 for Mac | DTX Studio™ Clinic | NOBEL BIOCARE AB |
20 | 07332747187038 | 2.4 | 300851 | DTX Studio Clinic 2.4 for Win 64-bit | DTX Studio™ Clinic | NOBEL BIOCARE AB |
21 | 07332747185850 | 2.3 | 300851 | DTX Studio Clinic 2.3 for Mac | DTX Studio™ Clinic | NOBEL BIOCARE AB |
22 | 07332747185843 | 2.3 | 300851 | DTX Studio Clinic 2.3 for Win 64-bit | DTX Studio™ Clinic | NOBEL BIOCARE AB |
23 | 07332747185836 | 2.3 | 300011 | IPS CaseDesigner 2.3 Mac | IPS CaseDesigner® | NOBEL BIOCARE AB |
24 | 07332747185829 | 2.3 | 300011 | IPS CaseDesigner 2.3 Win 64-bit | IPS CaseDesigner® | NOBEL BIOCARE AB |
25 | 07332747185775 | 1.9 | 300851 | DTX Studio Clinic 1.9 for Mac | DTX Studio™ Clinic | NOBEL BIOCARE AB |
26 | 07332747185768 | 1.9 | 300851 | DTX Studio Clinic 1.9 for Win 64-bit | DTX Studio™ Clinic | NOBEL BIOCARE AB |
27 | 07332747181944 | 3.6 | 300843 | DTX Studio Implant 3.6 for Mac | DTX Studio™ Implant | NOBEL BIOCARE AB |
28 | 07332747181937 | 3.6 | 300843 | DTX Studio Implant 3.6 for Windows 64-bit | DTX Studio™ Implant | NOBEL BIOCARE AB |
29 | 07332747181920 | 2.2 | 300011 | IPS CaseDesigner 2.2 Mac | IPS CaseDesigner® | NOBEL BIOCARE AB |
30 | 07332747181913 | 2.2 | 300011 | IPS CaseDesigner 2.2 Win 64-bit | IPS CaseDesigner® | NOBEL BIOCARE AB |
31 | 07332747178425 | 1.8 | 300851 | DTX Studio Clinic 1.8 for Mac | DTX Studio™ Clinic | NOBEL BIOCARE AB |
32 | 07332747178418 | 1.8 | 300851 | DTX Studio Clinic 1.8 for Win 64-bit | DTX Studio™ Clinic | NOBEL BIOCARE AB |
33 | 07332747178258 | 2.1 | 300011 | IPS CaseDesigner 2.1 Mac | IPS CaseDesigner® | NOBEL BIOCARE AB |
34 | 07332747178241 | 2.1 | 300011 | IPS CaseDesigner 2.1 Win 64-bit | IPS CaseDesigner® | NOBEL BIOCARE AB |
35 | 07332747172997 | 1.7 | 300851 | DTX Studio Clinic 1.7 for Mac | DTX Studio™ Clinic | NOBEL BIOCARE AB |
36 | 07332747172980 | 1.7 | 300851 | DTX Studio Clinic 1.7 for Win 64-bit | DTX Studio™ Clinic | NOBEL BIOCARE AB |
37 | 07332747172829 | 3.5 | 300843 | DTX Studio Implant 3.5 for Mac | DTX Studio™ Implant | NOBEL BIOCARE AB |
38 | 07332747172805 | 3.5 | 300843 | DTX Studio Implant 3.5 for Windows 64-bit | DTX Studio™ Implant | NOBEL BIOCARE AB |
39 | 07332747172065 | 2.0 | 300011 | IPS CaseDesigner 2.0 Mac | IPS CaseDesigner® | NOBEL BIOCARE AB |
40 | 07332747172058 | 2.0 | 300011 | IPS CaseDesigner 2.0 Win 64-bit | IPS CaseDesigner® | NOBEL BIOCARE AB |
41 | 07332747166408 | 1.6 | 300851 | DTX Studio Clinic 1.6 for Mac | DTX Studio™ Clinic | NOBEL BIOCARE AB |
42 | 07332747166392 | 1.6 | 300851 | DTX Studio Clinic 1.6 for Win 64-bit | DTX Studio™ Clinic | NOBEL BIOCARE AB |
43 | 07332747166125 | 3.4 | 300843 | DTX Studio Implant 3.4 for Mac | DTX Studio™ Implant | NOBEL BIOCARE AB |
44 | 07332747166101 | 3.4 | 300843 | DTX Studio Implant 3.4 for Win 64-bit | DTX Studio™ Implant | NOBEL BIOCARE AB |
45 | 07332747158809 | 3.3 | 300843 | DTX Studio Implant 3.3 for Mac | DTX Studio™ Implant | NOBEL BIOCARE AB |
46 | 07332747158793 | 3.3 | 300843 | DTX Studio Implant 3.3 for Win 64-bit | DTX Studio™ Implant | NOBEL BIOCARE AB |
47 | 07332747157673 | 1.4 | 300011 | IPS CaseDesigner 1.4 for MAC | IPS CaseDesigner™ | NOBEL BIOCARE AB |
48 | 07332747157666 | 1.4 | 300011 | IPS CaseDesigner 1.4 for Windows 64-bit | IPS CaseDesigner™ | NOBEL BIOCARE AB |
49 | 07332747153118 | 1.4 | 300123 | DTX Studio diagnose 1.4 for Mac | DTX Studio™ diagnose | NOBEL BIOCARE AB |
50 | 07332747153101 | 1.4 | 300123 | DTX Studio diagnose 1.4 for Windows 64-bit | DTX Studio™ diagnose | NOBEL BIOCARE AB |