Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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SENTINEL 10 / PATHFINDER SL KIT FR
SPACELABS HEALTHCARE (WASHINGTON), INC
98000
Not in Commercial Distribution

  • 10841522125010 ()
040-1748-00

  • Electrocardiographic long-term ambulatory recording analyser
CD ASSY PATHFINDER SL 1.9
SPACELABS HEALTHCARE (WASHINGTON), INC
Pathfinder SL
In Commercial Distribution

  • 10841522124617 ()
063-2468-00

  • Electrocardiographic long-term ambulatory recording analyser
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Ambulatory ECG Monitoring (Holter) Analysis - Support for data transfer via USB or SD Card Reader (for DL800/900 recorders) The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NH301-4
In Commercial Distribution

  • 07290110254995 ()
HASP-SW-K-NH301-4-04

  • Electrocardiographic long-term ambulatory recording analyser
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Ambulatory ECG Monitoring (Holter) Analysis - Support for data transfer via USB (for DL900 recorders) The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NH301-3
In Commercial Distribution

  • 07290110254988 ()
HASP-SW-K-NH301-4-03

  • Electrocardiographic long-term ambulatory recording analyser
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Ambulatory ECG Monitoring (Holter) Analysis, including support for NR via USB The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NH301-2
In Commercial Distribution

  • 07290110254971 ()
HASP-SW-K-NH301-4-02

  • Electrocardiographic long-term ambulatory recording analyser
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Nethasp Holter for additional work station, Kit The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NH301-N
In Commercial Distribution

  • 07290110252755 ()
HASP-SW-K-NH301-Net-1

  • Electrocardiographic long-term ambulatory recording analyser
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Network Solution for NH300 - No additional users The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NH300-N
In Commercial Distribution

  • 07290110252731 ()
HASP-SW-KNH300-3N-M-02

  • Electrocardiographic long-term ambulatory recording analyser
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Upgrade from SOFT-NH300-2/3 to SOFT-NH301-4,K The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NH300 Ana to 301
In Commercial Distribution

  • 07290110252717 ()
SW NH300 Ana to 301

  • Electrocardiographic long-term ambulatory recording analyser
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Upgrade from SOFT-NH300-1 to SOFT-NH301-4,Kit The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NH300 DL-Rv to 301
In Commercial Distribution

  • 07290110252694 ()
HASP-SW-KNH300-1-UP-1

  • Electrocardiographic long-term ambulatory recording analyser
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - NER = Event Recording Analysis Tool The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NER
In Commercial Distribution

  • 07290110252670 ()
HASP-SW-K-NER1-01

  • Electrocardiographic long-term ambulatory recording analyser
Product Description DeV IntelliPAP FLOW MANIFOLD
Drive Devilbiss Healthcare
DV5H-600
Not in Commercial Distribution

  • 00885304007470 ()


  • Ventilator IMV controller
Product Description IntelliPAP Std w/HH&SmrtLnk Mod.&Dta Crd
Drive Devilbiss Healthcare
DV51D-HH-S
Not in Commercial Distribution

  • 00885304001164 ()


  • Ventilator IMV controller
Respiratory Nebs Product Description FlexSet Cmft Tch Sil Msk size M
Drive Devilbiss Healthcare
9354DR
Not in Commercial Distribution

  • 00885304000280 ()


  • Ventilator IMV controller
DR181 holter recorder w/ 5L patient cable
Northeast Monitoring, Inc.
DR181 5L
In Commercial Distribution

  • M581NEMK1380 ()

  • Length: 12.5 Centimeter
  • Width: 7.0 Centimeter
  • Depth: 2.5 Centimeter
  • Weight: 200 Gram
NEMK138

  • Electrocardiographic long-term ambulatory recording analyser
An antistammering device intended to help individuals who stutter improve their level of fluency. The device modifies how users hear their own voice, supporting smoother and more controlled speech patterns by using Delayed Auditory Feedback (DAF) technology with a 70-millisecond time delay.
SPEAK FOR LESS LTD
FP-A01
In Commercial Distribution

  • 05070003548507 ()
  • 15070003548504 ()
  • 25070003548501 ()
  • 35070003548508 ()
  • 45070003548505 ()
  • 55070003548502 ()
  • 65070003548509 ()
  • 75070003548506 ()
  • 85070003548503 ()


  • Antistammering device
SWIFT FX NANO FOR HER MASK SYS
RESMED PTY LTD
62201
In Commercial Distribution

  • 00619498622016 ()
62201

  • CPAP/BPAP nasal mask, reusable
MIRAGE FX FOR HER SYS SML SLM
RESMED PTY LTD
62135
In Commercial Distribution

  • 00619498621354 ()
62135

  • CPAP/BPAP nasal mask, reusable
SWIFT FX BELLA+FOR HER HG-COMBO PK
RESMED PTY LTD
61580
In Commercial Distribution

  • 00619498615803 ()
61580

  • CPAP/BPAP nasal mask, reusable
AIRFIT F20 FOR HER FRAME SYS MED
RESMED PTY LTD
63464
In Commercial Distribution

  • 00619498634644 ()
63464

  • CPAP/BPAP face mask, reusable
AIRFIT F20 FOR HER FRAME SYS SML
RESMED PTY LTD
63463
In Commercial Distribution

  • 00619498634637 ()
63463

  • CPAP/BPAP face mask, reusable
AIRFIT N 10 FOR HER SYS- SLM
RESMED PTY LTD
63207
In Commercial Distribution

  • 00619498632077 ()
  • 00619498002412 ()
63207

  • CPAP/BPAP nasal mask, reusable
AIRFIT N 10 FOR HER MASK -SMALL
RESMED PTY LTD
63201
In Commercial Distribution

  • 00619498632015 ()
63201

  • CPAP/BPAP nasal mask, reusable
AIRFIT F 10 FOR HER HEADGEAR STD
RESMED PTY LTD
63167
In Commercial Distribution

  • 00619498631674 ()
63167

  • CPAP/BPAP face mask, reusable
AIRFIT P10 MASK SYS FOR HER SLM
RESMED PTY LTD
62927
In Commercial Distribution

  • 00619498629275 ()
  • 00619498002306 ()
62927

  • CPAP/BPAP nasal mask, reusable
AIRFIT P 10 FOR HER NASAL MASK
RESMED PTY LTD
62910
In Commercial Distribution

  • 00619498629107 ()
62910

  • CPAP/BPAP nasal mask, reusable
QUATTRO AIR FOR HER FFM EXTRA SML
RESMED PTY LTD
62740
In Commercial Distribution

  • 00619498627400 ()
62740

  • CPAP/BPAP face mask, reusable
QUATTRO FX FOR HER FRAME SYS MED
RESMED PTY LTD
62514
In Commercial Distribution

  • 00619498625147 ()
62514

  • CPAP/BPAP face mask, reusable
QUATTRO FX FOR HER FRAME SYS SML
RESMED PTY LTD
62513
In Commercial Distribution

  • 00619498625130 ()
62513

  • CPAP/BPAP face mask, reusable
MIRAGE FX/ FOR HER FRAME SYS SML
RESMED PTY LTD
62137
In Commercial Distribution

  • 00619498621378 ()
62137

  • CPAP/BPAP nasal mask, reusable
SWIFT FX FOR HER MASK SYS- AMER
RESMED PTY LTD
61540
In Commercial Distribution

  • 00619498615407 ()
61540

  • CPAP/BPAP nasal mask, reusable
SWIFT LT FOR HER TUBE RETAINER -PLASTIC
RESMED PTY LTD
60598
In Commercial Distribution

  • 00619498605989 ()
60598

  • CPAP/BPAP nasal mask, reusable
SWIFT LT FOR HER HEADGEAR BUCKLE TOP
RESMED PTY LTD
60597
In Commercial Distribution

  • 00619498605972 ()
  • 00619498605965 ()
60597

  • CPAP/BPAP nasal mask, reusable
SWIFT LT FOR HER MASK SYSTEM- SLM
RESMED PTY LTD
60594
In Commercial Distribution

  • 00619498605941 ()
60594

  • CPAP/BPAP nasal mask, reusable
Bed Pans- Stackable, Mauve
Dynarex Corporation
4231
In Commercial Distribution

  • 00616784423128 ()
  • 00616784423135 ()


  • Bedpan
Bed Pans- Fracture; Mauve
Dynarex Corporation
4230
In Commercial Distribution

  • 00616784423029 ()
  • 00616784423036 ()


  • Bedpan
Bariatric Bedpan Orange 6/cs 45/plt
MEDEGEN MEDICAL PRODUCTS, LLC
H133-15
In Commercial Distribution

  • 00700812001195 ()
  • 10700812001192 ()


  • Bedpan
Bedpan Conventional Rose 12/cs 15/plt
MEDEGEN MEDICAL PRODUCTS, LLC
H131-10
In Commercial Distribution

  • 00700812001188 ()
  • 10700812001185 ()


  • Bedpan
Bedpan Conventional Gold 12/cs 15/plt
MEDEGEN MEDICAL PRODUCTS, LLC
H131-05
In Commercial Distribution

  • 00700812001171 ()
  • 10700812001178 ()


  • Bedpan
Bedpan Conventional wCvr Gold 12/cs 15/p
MEDEGEN MEDICAL PRODUCTS, LLC
H130-05
In Commercial Distribution

  • 00700812001164 ()
  • 10700812001161 ()


  • Bedpan
Bedpan Pontoon wCvr Rose Bggd 10/cs 20/p
MEDEGEN MEDICAL PRODUCTS, LLC
H122-10
In Commercial Distribution

  • 00700812001157 ()
  • 10700812001154 ()


  • Bedpan
Bedpan Pontoon wCvr Gold Bggd 10/cs 20/p
MEDEGEN MEDICAL PRODUCTS, LLC
H122-05
In Commercial Distribution

  • 00700812001140 ()
  • 10700812001147 ()


  • Bedpan
Bedpan Pontoon Rose Bggd 20/cs 15/plt
MEDEGEN MEDICAL PRODUCTS, LLC
H120BG-10
In Commercial Distribution

  • 00700812001133 ()
  • 10700812001130 ()


  • Bedpan
Bedpan Pontoon Gold Bggd 20/cs 15/plt
MEDEGEN MEDICAL PRODUCTS, LLC
H120BG-05
In Commercial Distribution

  • 00700812001126 ()
  • 10700812001123 ()


  • Bedpan
Bedpan Pontoon Gray 20/cs 15/plt
MEDEGEN MEDICAL PRODUCTS, LLC
H120-11
In Commercial Distribution

  • 00700812001119 ()
  • 10700812001116 ()


  • Bedpan
Bedpan Pontoon Rose 20/cs 15/plt
MEDEGEN MEDICAL PRODUCTS, LLC
H120-10
In Commercial Distribution

  • 00700812001102 ()
  • 10700812001109 ()


  • Bedpan
Bedpan Pontoon Turq 20/cs 15/plt
MEDEGEN MEDICAL PRODUCTS, LLC
H120-07
In Commercial Distribution

  • 00700812001096 ()
  • 10700812001093 ()


  • Bedpan
Bedpan Pontoon Gold 20/cs 15/plt
MEDEGEN MEDICAL PRODUCTS, LLC
H120-05
In Commercial Distribution

  • 00700812001089 ()
  • 10700812001086 ()


  • Bedpan
Bedpan Stackable Large Gold 25/cs 27/plt
MEDEGEN MEDICAL PRODUCTS, LLC
H114-05
In Commercial Distribution

  • 00700812001072 ()
  • 10700812001079 ()


  • Bedpan
Bedpan Commode Gray 50/cs 36/plt
MEDEGEN MEDICAL PRODUCTS, LLC
H113-11
In Commercial Distribution

  • 00700812001065 ()
  • 10700812001062 ()


  • Bedpan
Bedpan Commode Rose 50/cs 36/plt
MEDEGEN MEDICAL PRODUCTS, LLC
H113-10
In Commercial Distribution

  • 00700812001058 ()
  • 10700812001055 ()


  • Bedpan
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