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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 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 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 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
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
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
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
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
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
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
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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