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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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AF541 - 00606959024502

AF541 Mask with Entrainment Elbow, Leak 1, with Capstrap, Large
Respironics, Inc.
AF541 Mask, EE, Leak 1 with Capstrap, Large
In Commercial Distribution

  • 30606959024503 ()
  • 00606959024502 ()
1121494

  • CPAP/BPAP face mask, single-use

AF541 - 00606959024496

AF541 Mask with Entrainment Elbow, Leak 1, with CapStrap, Medium
Respironics, Inc.
AF541 Mask, EE, Leak 1 with Capstrap, Medium
In Commercial Distribution

  • 30606959024497 ()
  • 00606959024496 ()
1121493

  • CPAP/BPAP face mask, single-use

DreamStation - 00606959022393

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

  • 00606959022393 ()
AHX200T11

  • Home CPAP unit

ComfortGel - 00606959022249

ComfortGel Blue Mask with Standard Elbow, with Headgear, Medium, International
Respironics, Inc.
ComfortGel Blue Mask w/SE, w/Headgear, Medium, INTL
In Commercial Distribution

  • 00606959022249 ()
1070069

  • CPAP/BPAP nasal mask, reusable

microTargeting™ Platform Accessory - 00873263004142

Peek Thumbknobs with Standoff, nonsterile. For use with microTargeting Platform
FHC, INC.
MP-KIT-MC-00414
In Commercial Distribution

  • 00873263004142 ()

  • Length: 20 Millimeter
MP-KIT-MC

  • Neurological stereotactic surgery system

Health o meter professional - 00851628008516

Antimicrobial Scale Assembled with Long Handrails, KG only with BT
Pelstar, LLC
3001KG-AMX-BT
In Commercial Distribution

  • 00851628008516 ()


  • Stand-on floor scale, electronic

Health o meter professional - 00851628008479

Antimicrobial Scale assembled with Height Rod, KG only with BT
Pelstar, LLC
3001KG-AMHR-BT
In Commercial Distribution

  • 00851628008479 ()


  • Stand-on floor scale, electronic

Health o meter professional - 00851628008448

Digital Platform Scale with Handrails and Height Rod with BT
Pelstar, LLC
3001KL-AM-BT
In Commercial Distribution

  • 00851628008448 ()


  • Stand-on floor scale, electronic

Health o meter professional - 00851628008295

Digital Platform Scale with Handrails and Height Rod with BT
Pelstar, LLC
2101KLHR-BT
In Commercial Distribution

  • 00851628008295 ()


  • Stand-on floor scale, electronic

Health o meter Professional - 00851628008240

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

  • 00851628008240 ()


  • Stand-on floor scale, electronic
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