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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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DreamStation - 00606959022607

DreamStation BiPAP Pro with Humidifier, with Heated Tube, American Home Patient (AHP)
Respironics, Inc.
DreamStation BiPAP Pro w/Humid w/H Tube, AHP
Not in Commercial Distribution

  • 00606959022607 ()
AHX600T11

  • Home BPAP unit

DreamStation - 00606959022454

DreamStation CPAP Pro with Humidifier, with Heated Tube, American Home Patient (AHP)
Respironics, Inc.
DreamStation CPAP Pro w/Humid w/H Tube, AHP
Not in Commercial Distribution

  • 00606959022454 ()
AHX400T11

  • Home CPAP unit

DELFIA Wash Concentrate - 06438147149865

For use with the DELFIA® Platewash after dilution with deionized water.
Wallac Oy
4010-0010
In Commercial Distribution

  • 06438147149865 ()
4010-0010

  • Buffered wash solution IVD

HexaLux - 00724995172473

The HexaLux Mobile Stand with Batteries is used with the HexaLux Light.
STERIS
HexaLux Light Mobile Stand
Not in Commercial Distribution

  • 00724995172473 ()
EXLMWBHUS

  • Fixed examination/treatment room light

CopperUnder sock Extra Large - 00850051939541

A sock made with 40% MODAACRYLIC infused with copper polyester Extra Large
SUN SCIENTIFIC, INC.
AW7025-02
In Commercial Distribution

  • 00850051939541 ()
CS400

  • Compression/pressure sock/stocking, reusable

CopperUnder sock Small/Medium - 00850051939527

A sock made with 40% MODAACRYLIC infused with copper polyester small/medium
SUN SCIENTIFIC, INC.
AW7025-00
In Commercial Distribution

  • 00850051939527 ()
CS150

  • Compression/pressure sock/stocking, reusable

Health o meter professional - 00851628008318

Digital platform scale with handrails and height rod, kg only with bt
Pelstar, LLC
2101KGHR-BT
In Commercial Distribution

  • 00851628008318 ()


  • Stand-on floor scale, electronic

Health o meter Professional - 00851628008264

Digital Platform Scale with Handrails and Height Rod, KG only with Bluetooth
Pelstar, LLC
1100KGHR-BT
In Commercial Distribution

  • 00851628008264 ()


  • Stand-on floor scale, electronic

Ventury Dry - 00860007020926

Accessory connector to be used with Venturi MicroDry, compatible with Olympus endoscope
GI Scientific LLC
Universal Connector with Auxiliary Jet Connector Olympus
In Commercial Distribution

  • 00860007020926 ()
VDU-06-00023

  • Surgical instrument/endoscope cleaning utensil, reusable

Orantech - 06941691968580

With inflation bag, Single tube, With connector Adult Extra Long Range 23-46cm
Orantech Inc.
BP-60BS-W44
In Commercial Distribution

  • 06941691968580 ()


  • Blood pressure cuff, reusable
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