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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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JOBST Elvarex - 04019702484601

Elvarex 1/Leg Extension from below knee to thigh/Thigh high slip form without volant to sew at body bandage/Navy
BSN-Jobst GmbH
77318-00062-00
In Commercial Distribution

  • 04019702484601 ()

  • Pressure: 18-21 mmHg


  • Compression/pressure sock/stocking, reusable

JOBST Elvarex - 04019702476170

Elvarex 3/Leg Extension from below knee to thigh/Thigh high slip form without volant to sew at body bandage/Navy
BSN-Jobst GmbH
77381-00074-00
In Commercial Distribution

  • 04019702476170 ()

  • Pressure: 34-46 mmHg


  • Compression/pressure sock/stocking, reusable

Resp-O2 Heat Moisture Exchanger (HME) 1500 With Integrated Flex Tube - 00840117318090

Tidal Volume Range(250-1500mL), Media(Foam), Dead Space(90mL), Breathing Resistance (1.6cm H2O at 60 L/min), Weight(15.5g). Adult/Pediatric
Dynarex Corporation
30202
In Commercial Distribution

  • 00840117318083 ()
  • 00840117318090 ()


  • Heat/moisture exchanger, single-use

Resp-O2 Heat Moisture Exchanger (HME) Tracheostomy with Side Oxygen Port - 00840117305885

Adult/Ped: Tidal Volume Range(300-1500mL), Breathing Resistance(1.8cm H2O at 60L/min, Media(Corrugated Paper), Dead Space(15mL), Weight(8.4g)
Dynarex Corporation
30309
In Commercial Distribution

  • 00840117305892 ()
  • 00840117305885 ()


  • Heat/moisture exchanger, single-use

Resp-O2 Heat Moisture Exchanger (HME) 600, HCH, CO2 Port - 00840117305472

Pediatric, Tidal Volume Range(70-600mL), Media(Foam), Dead Space(21mL), Breathing Resistance(2.2cm H2O at 60 L/min), Weight(9g), Pediatric
Dynarex Corporation
30205
In Commercial Distribution

  • 00840117305489 ()
  • 00840117305472 ()


  • Heat/moisture exchanger/microbial medical gas filter

Resp-O2 Hygroscopic Condenser Humidifier (HMEF) 600 B/V Filter, CO2 Port - 00840117305373

Pediatric, Tidal Volume Range(70-600mL), Media(Foam + Flat Media), Dead Space(19mL), Breathing Resistance(1.6cm H2O at 30L /min), Weight(19g)
Dynarex Corporation
30107
In Commercial Distribution

  • 00840117305380 ()
  • 00840117305373 ()


  • Heat/moisture exchanger/microbial medical gas filter

Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1000 CO2 Port, Low Profile - 00840117305311

Adult, Tidal Volume Range( 150-1000mL), Media (Foam+ Flat Media), Dead Space (43mL), Breathing Resistance (1.9cm H2O at 60L /min), Weight (21g)
Dynarex Corporation
30104
In Commercial Distribution

  • 00840117305328 ()
  • 00840117305311 ()


  • Heat/moisture exchanger/microbial medical gas filter

Jay - 00016958052015

The JAY J3 wheelchair cushion provides outstanding stability and optimal pressure distribution for the client at high risk of skin breakdown.
SUNRISE MEDICAL (US) LLC
J3
In Commercial Distribution

  • 00016958052015 ()
E2622, E2623, E2624, E2625

  • Gel-filled chair cushion
  • Air-filled chair cushion

Neotech Bridge® - 00812594013478

The Neotech Bridge is a breastfeeding assistance device intended to deliver supplemental nutrition to an infant latched at the breast/chest.
Neotech Products LLC
Kit – Bridge with Extension and 20ML & 60ML Syringes
In Commercial Distribution

  • 00812594013478 ()
N8001-Kit

  • Breast pump support kit, reusable

PCRopsis - B550227610000

PCRopsis™ BCS Nano (1000 mL) is intended for selective precipitation of red blood cells from whole blood at room temperature.
ENTOPSIS, LLC
BCS Nano
Not in Commercial Distribution

  • B550227610000 ()
22761000

  • Red blood cell separation reagent
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