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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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DreamStation - 00606959022454

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

  • 00606959022454 ()
AHX400T11

  • Home CPAP unit

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

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

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 - 00606959024397

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

  • 30606959024398 ()
  • 00606959024397 ()
1121061

  • CPAP/BPAP face mask, single-use

AF541 - 00606959024366

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

  • 30606959024367 ()
  • 00606959024366 ()
1121058

  • CPAP/BPAP face mask, single-use

AF541 - 00606959046696

AF541 Under the Nose Mask, with Standard Elbow, with Capstrap, SIZE B
Respironics, Inc.
AF541 Mask, SE, Under Nose, w/Capstrap, SIZE B
In Commercial Distribution

  • 30606959046697 ()
  • 00606959046696 ()
1133718

  • CPAP/BPAP face mask, single-use

AF541 - 00606959046689

AF541 Under the Nose Mask with Standard Elbow, with Capstrap, SIZE A
Respironics, Inc.
AF541 Mask, SE, Under Nose, w/Capstrap, SIZE A
In Commercial Distribution

  • 30606959046680 ()
  • 00606959046689 ()
1133717

  • CPAP/BPAP face mask, single-use

ACM - 04546540899071

Bowl with High Vacuum Blades and Cement Cartridge with Breakaway Femoral Nozzle
STRYKER CORPORATION
0306564000
In Commercial Distribution

  • 34546540899072 ()
  • 04546540899071 ()

  • Weight: 180.0 Gram
0306564000

  • Manual orthopaedic cement mixer, reusable

SurgiLav - 04546540860736

Plus Handpiece with Suction Tubing and Trauma Tip with Small Soft Cone
STRYKER CORPORATION
0207590000
In Commercial Distribution

  • 34546540860737 ()
  • 04546540860736 ()
0207590000

  • Disposable surgical irrigation/aspiration system
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