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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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NA - 04546540049018

Irrigation Tube Set with Accessories
STRYKER CORPORATION
0260901050
In Commercial Distribution

  • 04546540049018 ()
0260901050

  • Surgical irrigation tubing set, single-use

NA - 04546540039651

Femoral Sponge with Suction Attachment
STRYKER CORPORATION
0206714000
In Commercial Distribution

  • 34546540039652 ()
  • 04546540039651 ()
0206714000

  • Orthopaedic cement preparation/delivery kit

DreamStation - 00606959043299

DreamStation CPAP with Humidifier, Korea
Respironics, Inc.
DreamStation CPAP with Humidifier, KR
Not in Commercial Distribution

  • 00606959043299 ()
KRX200H15

  • Home CPAP unit

Dorma - 00606959036970

Dorma 200 with Humidifier, LA
Respironics, Inc.
Dorma 200, with Humidifier, LA
Not in Commercial Distribution

  • 00606959036970 ()
LAV201H

  • Home CPAP unit
  • Heated respiratory humidifier

Dorma 400 - 00606959036826

Dorma 400 with Humidifier, Germany
Respironics, Inc.
Dorma 400 with Humidifier, DE
In Commercial Distribution

  • 00606959036826 ()
DEV402H

  • Home CPAP unit
  • Heated respiratory humidifier

Dorma 200 - 00606959036802

Dorma 200 with Humidifier, France
Respironics, Inc.
Dorma 200 with Humidifier, FR
In Commercial Distribution

  • 00606959036802 ()
FRV201H

  • Home CPAP unit
  • Heated respiratory humidifier

AF811 - 00606959034358

AF811 Mask with Headgear, Medium
Respironics, Inc.
AF811 Mask with Headgear, Medium, Single Use
In Commercial Distribution

  • 30606959034359 ()
  • 00606959034358 ()
1120252

  • CPAP/BPAP face mask, single-use

AF811 - 00606959034341

AF811 Mask with Headgear, Large
Respironics, Inc.
AF811 Mask with Headgear, Large, Single Use
In Commercial Distribution

  • 30606959034342 ()
  • 00606959034341 ()
1120251

  • CPAP/BPAP face mask, single-use

DreamStation - 00606959034044

DreamStation CPAP with WiFi, USA
Respironics, Inc.
DreamStation CPAP w/WiFi, US
In Commercial Distribution

  • 00606959034044 ()
DSX200S11W

  • Home CPAP unit

REMstar System One 60 Series - 00606959030169

REMstar Pro, with BlueTooth, Canada
Respironics, Inc.
REMstar Pro w/BlueTooth, CA
In Commercial Distribution

  • 00606959030169 ()
461CABT

  • Home CPAP unit
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