No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00843997013956 | 4508 | DQA | Oximeter | 2 | SatShare | ||
2 | 00843997016278 | 4868 | LNCS SpO2 Patient Cable & Adult DBI Sensor | DQA | Oximeter | 2 | Patient Cable & Adult DBI Sensor | |
3 | 00843997016001 | 9992 | RD Single-patient Use Conversion Kit | DQA | Oximeter | 2 | RD | |
4 | 00843997014274 | 9917 | Radius-7 Conversion Kit | DQA | Oximeter | 2 | Radius-7 | |
5 | 00843997014267 | 9916 | Radius-7 Wearable Pulse CO-Oximeter | DQA | Oximeter | 2 | Radius-7 | |
6 | 00843997014144 | 9914 | Radius-7 with Wi-Fi Conversion Kit | DQA | Oximeter | 2 | Radius-7 | |
7 | 00843997014137 | 4547 | Radius-7 Wearable Instrument | MWI | Monitor, physiological, patient (without arrhythmia detection or alarms) | 2 | Radius-7 | |
8 | 00843997014120 | 4546 | Radius-7 with Wi-Fi Wearable Instrument | MWI | Monitor, physiological, patient (without arrhythmia detection or alarms) | 2 | Radius-7 | |
9 | 00843997014106 | 9903 | Radius-7 Wearable Pulse CO-Oximeter with Wi-Fi | DQA | Oximeter | 2 | Radius-7 | |
10 | 00843997013918 | 4513 | rainbow SET Module | DQA | Oximeter | 2 | rainbow SET | |
11 | 00843997012997 | 9837 | with Wi-Fi | DQA | Oximeter | 2 | Radius-7 | |
12 | 00843997012447 | 9756 | External Module | DQA | Oximeter | 2 | SatShare | |
13 | 00843997011945 | 1367 | DQA | Oximeter | 2 | SatShare™ Interface NK01 Cable | ||
14 | 00843997011686 | 4251 | DQA | Oximeter | 2 | Red LNC MD20-01 LNCS® Patient Cable | ||
15 | 00843997011662 | 4256 | DQA | Oximeter | 2 | RD Rainbow SET™ M20-05 RD rainbow SET Series Patient Cable | ||
16 | 00843997011648 | 4100 | BZQ | Monitor, breathing frequency | 2 | rainbow SET | ||
17 | 00843997011143 | 1840 | DQA | Oximeter | 2 | SatShare™ Interface PM01 Cable | ||
18 | 00843997011112 | 1595 | DQA | Oximeter | 2 | SatShare™ Interface AT01 Cable | ||
19 | 00843997011082 | 1362 | DQA | Oximeter | 2 | SatShare™ Interface SL02 Cable | ||
20 | 00843997010160 | 4093 | DQA | Oximeter | 2 | M-LNCS™ to RD Adapter Cable M-LNCS to RD SET™ or RD rainbow SET™ Patient Cable | ||
21 | 00843997010115 | 4088 | DQA | Oximeter | 2 | RD to PC Adapter Cable RD SET™ to PC Adapter Cable | ||
22 | 00843997010047 | 4196 | Radius-7 Wearable Instrument | MWI | Monitor, physiological, patient (without arrhythmia detection or alarms) | 2 | Radius-7 | |
23 | 00843997009751 | 4080 | DQA | Oximeter | 2 | RD SET™ MD14-05 RD SET Series Patient Cable | ||
24 | 00843997009737 | 4072 | DQA | Oximeter | 2 | RD rainbow SET™ MD20-05 RD rainbow SET Series Patient Cable | ||
25 | 00843997009683 | 3984 | DQA | Oximeter | 2 | LNC-10 to NK LNCS® to NK Patient Cable | ||
26 | 00843997009393 | 1872 | DQA | Oximeter | 2 | ProCal+™ CBL MASIMO INT SpO2 1.5M | ||
27 | 00843997009386 | 1604 | DQA | Oximeter | 2 | ProCal+™ Masimo Cable ProCal 2M | ||
28 | 00843997009249 | 9664 | Radius-7 Wearable Pulse CO-Oximeter | DQA | Oximeter | 2 | Radius-7 | |
29 | 00843997009195 | 3935 | DQA | Oximeter | 2 | MasimoSET®Red 25 LNC-1 LNCS® Patient Cable for SpO2 | ||
30 | 00843997008921 | 9167 | DQA | Oximeter | Pronto™ Pulse CO-Oximeter® | |||
31 | 00843997007887 | 3630 | DQA | Oximeter | 2 | MasimoSET® Red 25 LNC-4 LNCS® Patient Cable for SpO2 | ||
32 | 00843997007719 | 3587 | OCH,PGJ | oximeter, infrared, sporting, aviation,Oximeter, wellness | 2 | iSpO2 Pulse Oximeter Consumer (Large) | ||
33 | 00843997006835 | 3343 | DQA | Oximeter | 2 | MasimoSET® rainbow® RC25-12RA rainbow® Patient Cable | ||
34 | 00843997006699 | 1841 | DQA | Oximeter | 2 | MasimoSET® VueLink® Cable | ||
35 | 00843997006538 | 9213 | DQA | Oximeter | Rad-8® Vertical signal extraction pulse oximeter | |||
36 | 00843997006347 | 9178 | DQA | Oximeter | Radical-7™ Color Screen Handheld signal extraction pulse co-oximeter® | |||
37 | 00843997005944 | 2373 | DQA | Oximeter | 2 | PXC2-30 Mountable Extension Cable | ||
38 | 00843997005630 | 9191 | DQA | Oximeter | Rad-8® Vertical signal extraction pulse oximeter | |||
39 | 00843997004848 | 1927 | DQA | Oximeter | 2 | MasimoSET® MAC-1 LNOP® SpO2 Patient Cable | ||
40 | 00843997003940 | 2750 | DQA | Oximeter | 2 | M-LNCS to LNC MAC Adapter Cable M-LNCS to LNC MAC Spacelabs Patient Cable | ||
41 | 00843997003933 | 2654 | DQA | Oximeter | 2 | MasimoSET® M-LNCS® to LNC Adapter Cable | ||
42 | 00843997003766 | 2536 | DQA | Oximeter | 2 | MasimoSET® M-LNC-14-DB9 M-LNCS™ to DB9 Patient Cable | ||
43 | 00843997003247 | 2504 | DQA | Oximeter | 2 | MasimoSET® M-LNCS™ TF-I SpO2 Adult Reusable Forehead Sensor | ||
44 | 00843997003131 | 2526 | DQA | Oximeter | 2 | MasimoSET® M-LNC-14 M-LNCS™ Series Patient Cable | ||
45 | 00843997001748 | 9086 | DQA | Oximeter | Radical-7™ Color Screen Handheld signal extraction pulse co-oximeter® | |||
46 | 00843997001267 | 2056 | DQA | Oximeter | 2 | MasimoSET Red LNC-10 LNCS® Patient Cable | ||
47 | 00843997001205 | 2288 | DQA | Oximeter | 2 | MasimoSET® PC-04-DB9 LNOP® to DB9 Connector Patient Cable | ||
48 | 00843997000567 | 2017 | DQA | Oximeter | 2 | MasimoSET LNC-04 LNCS® Series Patient Cable | ||
49 | 00843997000543 | 2013 | DQA | Oximeter | 2 | MasimoSET LNC-14 LNCS® Series Patient Cable | ||
50 | 00843997000109 | 1396 | DQA | Oximeter | 2 | DCSC SpO2 Adult Reusable Sensor |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | B322D0011 | D001 | To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pu To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate. To analyze the pulse waveform (Photoelectrical Plethysmography or PP) provided by the oximeter. It only provides mathematical analyses of the input of the SpO2 measurement. To analyze the basic rhythms of the NN or RR intervals in heart rate, both in the time domain and in the frequency domain (short time 5 minutes). It only provides mathematical analysis of the input of the heart rate variability. The mathematical analysis of Photoelectrical Plethysmography and HRV ARE NOT intended use for diagnosis. The software provides a visual alarm for the values of the heart rate and/or SpO2 percent out of the normal range and for the bad quality signal transmission. The data are stored in PC in the Backup system of the LD-Oxi software. The device is intended use only for adult subjects (> 20 years old) This Oximeter is intended to be used in spot-checking (5 minutes). The device is intended use in licensed practitioner’s office This device is no intended to be used at home, in hospital or out-of-hospital transport The device is not intended use in support life and not for continuously monitoring The system will be use by practitioner. | LD-Oxy | LD TECHNOLOGY, LLC | |
2 | B322B0011 | B001 | The T- Oxi device indicated for use in non- The vital signs monitor is a portabl The T- Oxi device indicated for use in non- The vital signs monitor is a portable device invasively measuring and displaying functional indicated for use in non-invasively oxygen saturation of arterial hemoglobin (SpO2 ), measuring and displaying functional oxygen pulse rate (PR), Non-invasive measurement of saturation of arterial hemoglobin blood pressure (NIBP) of adult patients in (SpO2 ), pulse rate (PR), Non-invasive medical facilities, measurement of blood pressure (NIBP) of TheTM-Oxi device is intended for spot-checking adult and pediatric patients in hospitals, of patients. medical facilities, and sub-acute environments. The vital sign monitor is intended for spot-checking and/or continuous monitoring of patients. | TM-Oxi System | LD TECHNOLOGY, LLC | |
3 | B299780NPMP0 | Datalys 780 | Multi-parameter patient monitor. 780-N-pM-P | Lutech | LUTECH INDUSTRIES INC | |
4 | B299780NPMO2P0 | Datalys 780 | Multi-parameter patient monitor. 780-N-pMO2-P | Lutech | LUTECH INDUSTRIES INC | |
5 | B299780NPMO20 | Datalys 780 | Multi-parameter patient monitor. 780-N-pMO2 | Lutech | LUTECH INDUSTRIES INC | |
6 | B299780NPM0 | Datalys 780 | Multi-parameter patient monitor. 780-N-pM | Lutech | LUTECH INDUSTRIES INC | |
7 | B299780NP0 | Datalys 780 | Multi-parameter patient monitor. 780-N-P | Lutech | LUTECH INDUSTRIES INC | |
8 | B299780NIPMP0 | Datalys 780 | Multi-parameter patient monitor. 780-N-I-pM-P | Lutech | LUTECH INDUSTRIES INC | |
9 | B299780NIPMO2P0 | Datalys 780 | Multi-parameter patient monitor. 780-N-I-pMO2-P | Lutech | LUTECH INDUSTRIES INC | |
10 | B299780NIPMO20 | Datalys 780 | Multi-parameter patient monitor. 780-N-I-pMO2 | Lutech | LUTECH INDUSTRIES INC | |
11 | B299780NIPM0 | Datalys 780 | Multi-parameter patient monitor. 780-N-I-pM | Lutech | LUTECH INDUSTRIES INC | |
12 | B299780NIP0 | Datalys 780 | Multi-parameter patient monitor. 780-N-I-P | Lutech | LUTECH INDUSTRIES INC | |
13 | B299780NICP0 | Datalys 780 | Multi-parameter patient monitor. 780-N-IC-P | Lutech | LUTECH INDUSTRIES INC | |
14 | B299780NICOP0 | Datalys 780 | Multi-parameter patient monitor. 780-N-I-CO-P | Lutech | LUTECH INDUSTRIES INC | |
15 | B299780NICO0 | Datalys 780 | Multi-parameter patient monitor. 780-N-I-CO | Lutech | LUTECH INDUSTRIES INC | |
16 | B299780NICCOP0 | Datalys 780 | Multi-parameter patient monitor. 780-N-IC-CO-P | Lutech | LUTECH INDUSTRIES INC | |
17 | B299780NICCO0 | Datalys 780 | Multi-parameter patient monitor. 780-N-IC-CO | Lutech | LUTECH INDUSTRIES INC | |
18 | B299780NIC0 | Datalys 780 | Multi-parameter patient monitor. 780-N-IC | Lutech | LUTECH INDUSTRIES INC | |
19 | B299780NI0 | Datalys 780 | Multi-parameter patient monitor. 780-N-I | Lutech | LUTECH INDUSTRIES INC | |
20 | B299780NCP0 | Datalys 780 | Multi-parameter patient monitor. 780-N-C-P | Lutech | LUTECH INDUSTRIES INC | |
21 | B299780NCO0 | Datalys 780 | Multi-parameter patient monitor. 780-N-CO | Lutech | LUTECH INDUSTRIES INC | |
22 | B299780NC0 | Datalys 780 | Multi-parameter patient monitor. 780-N-C | Lutech | LUTECH INDUSTRIES INC | |
23 | B299780N0 | Datalys 780 | Multi-parameter patient monitor. 780-N | Lutech | LUTECH INDUSTRIES INC | |
24 | B299780MPMP0 | Datalys 780 | Multi-parameter patient monitor. 780-M-pM-P | Lutech | LUTECH INDUSTRIES INC | |
25 | B299780MPMO2P0 | Datalys 780 | Multi-parameter patient monitor. 780-M-pMO2-P | Lutech | LUTECH INDUSTRIES INC | |
26 | B299780MPMO20 | Datalys 780 | Multi-parameter patient monitor. 780-M-pMO2 | Lutech | LUTECH INDUSTRIES INC | |
27 | B299780MPM0 | Datalys 780 | Multi-parameter patient monitor. 780-M-pM | Lutech | LUTECH INDUSTRIES INC | |
28 | B299780MP0 | Datalys 780 | Multi-parameter patient monitor. 780-M-P | Lutech | LUTECH INDUSTRIES INC | |
29 | B299780MIPMP0 | Datalys 780 | Multi-parameter patient monitor. 780-M-I-pM-P | Lutech | LUTECH INDUSTRIES INC | |
30 | B299780MIPMO2P0 | Datalys 780 | Multi-parameter patient monitor. 780-M-I-pMO2-P | Lutech | LUTECH INDUSTRIES INC | |
31 | B299780MIPMO20 | Datalys 780 | Multi-parameter patient monitor. 780-M-I-pMO2 | Lutech | LUTECH INDUSTRIES INC | |
32 | B299780MIPM0 | Datalys 780 | Multi-parameter patient monitor. 780-M-I-pM | Lutech | LUTECH INDUSTRIES INC | |
33 | B299780MIP0 | Datalys 780 | Multi-parameter patient monitor. 780-M-I-P | Lutech | LUTECH INDUSTRIES INC | |
34 | B299780MICP0 | Datalys 780 | Multi-parameter patient monitor. 780-M-IC-P | Lutech | LUTECH INDUSTRIES INC | |
35 | B299780MICOP0 | Datalys 780 | Multi-parameter patient monitor. 780-M-I-CO-P | Lutech | LUTECH INDUSTRIES INC | |
36 | B299780MICO0 | Datalys 780 | Multi-parameter patient monitor. 780-M-I-CO | Lutech | LUTECH INDUSTRIES INC | |
37 | B299780MICCOP0 | Datalys 780 | Multi-parameter patient monitor. 780-M-IC-CO-P | Lutech | LUTECH INDUSTRIES INC | |
38 | B299780MICCO0 | Datalys 780 | Multi-parameter patient monitor. 780-M-IC-CO | Lutech | LUTECH INDUSTRIES INC | |
39 | B299780MIC0 | Datalys 780 | Multi-parameter patient monitor. 780-M-IC | Lutech | LUTECH INDUSTRIES INC | |
40 | B299780MI0 | Datalys 780 | Multi-parameter patient monitor. 780-M-I | Lutech | LUTECH INDUSTRIES INC | |
41 | B299780MCP0 | Datalys 780 | Multi-parameter patient monitor. 780-M-C-P | Lutech | LUTECH INDUSTRIES INC | |
42 | B299780MC0 | Datalys 780 | Multi-parameter patient monitor. 780-M-C | Lutech | LUTECH INDUSTRIES INC | |
43 | B299780M0 | Datalys 780 | Multi-parameter patient monitor. 780-M | Lutech | LUTECH INDUSTRIES INC | |
44 | B299780LPMP0 | Datalys 780 | Multi-parameter patient monitor. 780-L-pM-P | Lutech | LUTECH INDUSTRIES INC | |
45 | B299780LPMO2P0 | Datalys 780 | Multi-parameter patient monitor. 780-L-pMO2-P | Lutech | LUTECH INDUSTRIES INC | |
46 | B299780LPMO20 | Datalys 780 | Multi-parameter patient monitor. 780-L-pMO2 | Lutech | LUTECH INDUSTRIES INC | |
47 | B299780LPM0 | Datalys 780 | Multi-parameter patient monitor. 780-L-pM | Lutech | LUTECH INDUSTRIES INC | |
48 | B299780LP0 | Datalys 780 | Multi-parameter patient monitor. 780-L-P | Lutech | LUTECH INDUSTRIES INC | |
49 | B299780LIPMP0 | Datalys 780 | Multi-parameter patient monitor. 780-L-I-pM-P | Lutech | LUTECH INDUSTRIES INC | |
50 | B299780LIPMO2P0 | Datalys 780 | Multi-parameter patient monitor. 780-L-I-pMO2-P | Lutech | LUTECH INDUSTRIES INC |