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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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AF531 - 00606959028968

AF531 Mask with Entrainment Elbow, Leak 1, with CapStrap, Single, Medium, China
Respironics, Inc.
AF531 Mask EE, Leak1 with CapStrap, Medium, China
Not in Commercial Distribution

  • 00606959028968 ()
CN1061728

  • CPAP/BPAP face mask, single-use

DreamStation - 00606959025707

DreamStation Auto BiPAP with Humidifier, with Heated Tube, and Cellular Modem, USA
Respironics, Inc.
DreamStation Auto BiPAP w/Humid w/H Tube, w/Cell, US
In Commercial Distribution

  • 00606959025707 ()
DSX700T11C

  • Home BPAP unit

AF541 - 00606959024540

AF541 Mask with Entrainment Elbow, Leak 2, with Four Point Headgear, Large
Respironics, Inc.
AF541 Mask EE, Leak 2 with 4-Point Headgear, Large
In Commercial Distribution

  • 30606959024541 ()
  • 00606959024540 ()
1121068

  • CPAP/BPAP face mask, single-use

AF541 - 00606959024465

AF541 Mask with Entrainment Elbow, Leak 1, with 4 Point Headgear, Large
Respironics, Inc.
AF541 Mask EE Leak 1, with 4 Point Headgear, Large
In Commercial Distribution

  • 30606959024466 ()
  • 00606959024465 ()
1121490

  • CPAP/BPAP face mask, single-use

AF541 - 00606959024458

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

  • 30606959024459 ()
  • 00606959024458 ()
1121489

  • CPAP/BPAP face mask, single-use

AF541 - 00606959024441

AF541 Mask with Entrainment Elbow, Leak 1, with 4 Point Headgear, Small
Respironics, Inc.
AF541 Mask EE, Leak 1, with 4 Point Headgear, Small
In Commercial Distribution

  • 30606959024442 ()
  • 00606959024441 ()
1121488

  • CPAP/BPAP face mask, single-use

AMARA - 00606959015012

Amara Mask with Standard Elbow with RS Frame and Headgear, International, Small
Respironics, Inc.
Amara Mask with SE, Small, with RS Frame and Headgear, INTL
In Commercial Distribution

  • 00606959015012 ()
1090231

  • CPAP/BPAP face mask, reusable

MSI Precision Specialty Instruments - 00194613094928

D'Assumpcao Facelift Marker With Ratchet 6" (152mm) With A Width Of 8mm
Med Saver, Inc.
402P
In Commercial Distribution

  • 00194613094928 ()


  • Skin marking guide, reusable

MSI Precision Specialty Instruments - 00194613094607

Silver Osteotome Straight With Overall Length 7" (178mm) With Single Guard Straight
Med Saver, Inc.
E8100
In Commercial Distribution

  • 00194613094607 ()


  • Orthopaedic osteotome

MSI Precision Specialty Instruments - 00194613079512

Bishop Bone Holidng Forcep With Overall Length 9" (229mm) With Adjustable Jaw
Med Saver, Inc.
D7202
In Commercial Distribution

  • 00194613079512 ()


  • Orthopaedic bone-fragment manipulator, reusable
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