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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 - 00606959024373

AF541 Mask with Entrainment Elbow, Leak 1, with Four-Point Headgear, Medium
Respironics, Inc.
AF541 Mask EE, Leak 1 w/ 4 Point Headgear,Medium
In Commercial Distribution

  • 30606959024374 ()
  • 00606959024373 ()
1121059

  • CPAP/BPAP face mask, single-use

DreamStation - 00606959040625

DreamStation BiPAP autoSV, with Humidifier, with Heated Tube, no BlueTooth, International
Respironics, Inc.
DreamStation BiPAP autoSV, w/Hum w/HTube, no BT, INTL
In Commercial Distribution

  • 00606959040625 ()
INX900T19

  • Portable electric ventilator

WISP - 00606959040090

Wisp Nasal Mask with Standard Elbow, with Headgear, Clear Frame, Japan
Respironics, Inc.
Wisp Nasal Mask w/SE, with Headgear, Clear Frame, JP
Not in Commercial Distribution

  • 00606959040090 ()
1094070

  • CPAP/BPAP nasal mask, reusable

Orantech - 06970706369081

With inflation bag, Double tube, With connector Large Adult Range 31-40cm
Orantech Inc.
BP-70BD-WD11
In Commercial Distribution

  • 06970706369081 ()


  • Blood pressure cuff, reusable

Orantech - 06970706369050

With inflation bag, Double tube, With connector Small Adult Range 17-25cm
Orantech Inc.
BP-40BD-WD11
In Commercial Distribution

  • 06970706369050 ()


  • Blood pressure cuff, reusable

Orantech - 06970706368992

With inflation bag, Double tube, With connector Large Adult Range 31-40cm
Orantech Inc.
BP-70BD-W1011
In Commercial Distribution

  • 06970706368992 ()


  • Blood pressure cuff, reusable

Orantech - 06970706368961

With inflation bag, Double tube, With connector Small Adult Range 17-25cm
Orantech Inc.
BP-40BD-W1011
In Commercial Distribution

  • 06970706368961 ()


  • Blood pressure cuff, reusable

Orantech - 06970706368909

With inflation bag, Double tube, With connector Large Adult Range 31-40cm
Orantech Inc.
BP-70BD-WD08
In Commercial Distribution

  • 06970706368909 ()


  • Blood pressure cuff, reusable

Orantech - 06970706368879

With inflation bag, Double tube, With connector Small Adult Range 17-25cm
Orantech Inc.
BP-40BD-WD08
In Commercial Distribution

  • 06970706368879 ()


  • Blood pressure cuff, reusable

Orantech - 06970706368817

With inflation bag, Single tube, With connector Large Adult Range 31-40cm
Orantech Inc.
BP-70BS-W11
In Commercial Distribution

  • 06970706368817 ()


  • Blood pressure cuff, reusable
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