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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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REMstar SE - 00606959037090

REMstar SE Auto, with Heated Humidifier, with SD Slot, Domestic
Respironics, Inc.
REMstar SE Auto, w/Heated Tube Humid and SD Slot, US
In Commercial Distribution

  • 00606959037090 ()
DS520TS

  • Heated respiratory humidifier
  • Home CPAP unit

REMstar SE - 00606959036765

REMstar SE Auto with Heated Humidifier, with SD Slot, Canada
Respironics, Inc.
REMstar SE Auto with Heated Humidifier, w/SD Slot, CA
In Commercial Distribution

  • 00606959036765 ()
CA521TS

  • Home CPAP unit
  • Heated respiratory humidifier

DreamStation - 00606959028593

DreamStation Auto BiPAP with Humidifier, with Heated Tube, Latin America
Respironics, Inc.
DreamStation Auto BiPAP w/Humid, w/H Tube, LA
In Commercial Distribution

  • 00606959028593 ()
LAX700T15

  • Home BPAP unit

DreamStation - 00606959028562

DreamStation BiPAP Pro with Humidifier, with Heated Tube, Latin America
Respironics, Inc.
DreamStation BiPAP Pro w/Humid w/H Tube, Latin America
In Commercial Distribution

  • 00606959028562 ()
LAX600T15

  • Home BPAP unit

DreamStation - 00606959028531

DreamStation Auto CPAP with Humidifier, with Heated Tube, Latin America
Respironics, Inc.
DreamStation Auto CPAP w/Humidifier, w/H Tube, LA
In Commercial Distribution

  • 00606959028531 ()
LAX500T15

  • Home CPAP unit

DreamStation - 00606959028500

DreamStation CPAP Pro with Humidifier, with Heated Tube, Latin America
Respironics, Inc.
DreamStation CPAP Pro w/Humid w/H Tube, LA
In Commercial Distribution

  • 00606959028500 ()
LAX400T15

  • Home CPAP unit

PERFORMATRAK - 00606959028449

PERFORMATRAK FULL MASK WITH STANDARD ELBOW, WITH CAPSTRAP, LARGE, INTERNATIONAL
Respironics, Inc.
PERFORMATRAK FULL SE W CAPSTRAP, INT, LARGE
In Commercial Distribution

  • 30606959028440 ()
  • 00606959028449 ()
1126378

  • CPAP/BPAP face mask, single-use

PERFORMATRAK - 00606959028432

PERFORMATRAK FULL MASK WITH STANDARD ELBOW, WITH CAPSTRAP, LARGE, JAPAN
Respironics, Inc.
PERFORMATRAK FULL SE W CAPSTRAP, JP, LARGE
Not in Commercial Distribution

  • 30606959028433 ()
  • 00606959028432 ()
1126377

  • CPAP/BPAP face mask, single-use

PERFORMATRAK - 00606959028425

PERFORMATRAK FULL MASK WITH STANDARD ELBOW, WITH CAPSTRAP, MEDIUM, INTERNATIONAL
Respironics, Inc.
PERFORMATRAK FULL SE W CAPSTRAP, INT, MEDIUM
In Commercial Distribution

  • 30606959028426 ()
  • 00606959028425 ()
1126376

  • CPAP/BPAP face mask, single-use

PERFORMATRAK - 00606959028418

PERFORMATRAK FULL MASK, WITH STANDARD ELBOW WITH CAPSTRAP, MEDIUM, JAPAN
Respironics, Inc.
PERFORMATRAK FULL SE W CAPSTRAP, JP, MEDIUM
Not in Commercial Distribution

  • 30606959028419 ()
  • 00606959028418 ()
1126375

  • CPAP/BPAP face mask, single-use

PERFORMATRAK - 00606959028401

PERFORMATRAK FULL MASK WITH STANDARD ELBOW WITH CAPSTRAP, SMALL, INTERNATIONAL
Respironics, Inc.
PERFORMATRAK FULL SE W CAPSTRAP, INT, SMALL
In Commercial Distribution

  • 30606959028402 ()
  • 00606959028401 ()
1126374

  • CPAP/BPAP face mask, single-use

PERFORMATRAK - 00606959028395

PERFORMATRAK FULL MASK WITH STANDARD ELBOW WITH CAPSTRAP, SMALL, JAPAN
Respironics, Inc.
PERFORMATRAK FULL SE W CAPSTRAP, JPN, SMALL
Not in Commercial Distribution

  • 30606959028396 ()
  • 00606959028395 ()
1126373

  • CPAP/BPAP face mask, single-use

PERFORMATRAK - 00606959027701

Performatrak Mask with Standard Elbow, with Headgear, Dispossable, Medium, Korea
Respironics, Inc.
Performatrak SE Mask w/Headgear, Disp, MEDIUM, KR
Not in Commercial Distribution

  • 30606959027702 ()
  • 00606959027701 ()
1119725

  • CPAP/BPAP face mask, single-use

PERFORMATRAK - 00606959027688

Performatrak Mask with Standard Elbow, with Headgear, Disposable, Large, Korea
Respironics, Inc.
Performatrak SE Mask w/Headgear, Disp, LARGE, KR
Not in Commercial Distribution

  • 30606959027689 ()
  • 00606959027688 ()
1119726

  • CPAP/BPAP face mask, single-use

AF541 - 00606959024588

AF541 Mask with Entrainment Elbow, Leak 2, with CapStrap, Large
Respironics, Inc.
AF541 Mask, EE, LEAK 2, WITH CAPSTRAP, LARGE
In Commercial Distribution

  • 30606959024589 ()
  • 00606959024588 ()
1121072

  • CPAP/BPAP face mask, single-use

AF541 - 00606959024571

AF541 Mask with Entrainment Elbow, Leak 2, with CapStrap, Medium
Respironics, Inc.
AF541 Mask, EE, LEAK 2 WITH CAPSTRAP, MEDIUM
In Commercial Distribution

  • 30606959024572 ()
  • 00606959024571 ()
1121071

  • CPAP/BPAP face mask, single-use

AF541 - 00606959024564

AF541 Mask with Entrainment Elbow, Leak 2, with CapStrap, Small
Respironics, Inc.
AF541 Mask, EE, LEAK 2, WITH CAPSTRAP, SMALL
In Commercial Distribution

  • 30606959024565 ()
  • 00606959024564 ()
1121070

  • CPAP/BPAP face mask, single-use

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

Orantech - 06941691968566

With inflation bag, Single tube, With connector Child Range 12-19cm
Orantech Inc.
BP-30BS-W44
In Commercial Distribution

  • 06941691968566 ()


  • Blood pressure cuff, reusable

Orantech - 06941691968559

With inflation bag, Single tube, With connector Infant Range 8-13cm
Orantech Inc.
BP-20BS-W44
In Commercial Distribution

  • 06941691968559 ()


  • Blood pressure cuff, reusable

Orantech - 06941691968542

With inflation bag, Single tube, With connector Neonatal Range 6-11cm
Orantech Inc.
BP-10BS-W44
In Commercial Distribution

  • 06941691968542 ()


  • Blood pressure cuff, reusable

Orantech - 06941691968184

With inflation bag, Single tube, With connector Adult Range 25-35cm
Orantech Inc.
M-BP-50BS
In Commercial Distribution

  • 06941691968184 ()


  • Blood pressure cuff, reusable

Orantech - 06941691968160

With inflation bag, Single tube, With connector Child Range 10-19cm
Orantech Inc.
M-BP-30BS
In Commercial Distribution

  • 06941691968160 ()


  • Blood pressure cuff, reusable

Orantech - 06941691961918

With inflation bag, Single tube, With connector Thigh Range 38-50cm
Orantech Inc.
BP-90BS-W44
In Commercial Distribution

  • 06941691961918 ()


  • Blood pressure cuff, reusable

Orantech - 06941691961864

With inflation bag, Single tube, With connector Child Range 12-19cm
Orantech Inc.
BP-30BS-W44
In Commercial Distribution

  • 06941691961864 ()


  • Blood pressure cuff, reusable

Orantech - 06941691961857

With inflation bag, Single tube, With connector Infant Range 8-13cm
Orantech Inc.
BP-20BS-W44
In Commercial Distribution

  • 06941691961857 ()


  • Blood pressure cuff, reusable

Orantech - 06941691961840

With inflation bag, Single tube, With connector Neonatal Range 6-11cm
Orantech Inc.
BP-10BS-W44
In Commercial Distribution

  • 06941691961840 ()


  • Blood pressure cuff, reusable

Orantech - 06941691958697

With inflation bag, Double tube, With connector Thigh Range 38-50cm
Orantech Inc.
BP-90BD-W38
In Commercial Distribution

  • 06941691958697 ()


  • Blood pressure cuff, reusable

Orantech - 06941691958659

With inflation bag, Double tube, With connector Adult Range 23-33cm
Orantech Inc.
BP-50BD-W38
In Commercial Distribution

  • 06941691958659 ()


  • Blood pressure cuff, reusable

Orantech - 06941691958635

With inflation bag, Double tube, With connector Infant Range 8-13cm
Orantech Inc.
BP-20BD-W38
In Commercial Distribution

  • 06941691958635 ()


  • Blood pressure cuff, reusable

Orantech - 06941691957980

With inflation bag, Single tube, With connector Adult Range 23-33cm
Orantech Inc.
BP-50BS-W44
In Commercial Distribution

  • 06941691957980 ()


  • Blood pressure cuff, reusable
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