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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

REMstar System One 60 Series - 00606959042858

REMstar Auto, with Bluetooth, USA
Respironics, Inc.
REMStar Auto w/BlueTooth, US
In Commercial Distribution

  • 00606959042858 ()
560PBT

  • Home CPAP unit

DreamStation - 00606959042124

DreamStation CPAP with Humidifier, China
Respironics, Inc.
DreamStation CPAP with Humidifier, CN
Not in Commercial Distribution

  • 00606959042124 ()
CNX200H17

  • Home CPAP unit

Dorma 200 - 00606959036727

Dorma 200 with Humidifier, AH
Respironics, Inc.
Dorma 200, with Humidifier, AH
In Commercial Distribution

  • 00606959036727 ()
AHV200H

  • Home CPAP unit
  • Heated respiratory humidifier

AF811 - 00606959034365

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

  • 30606959034366 ()
  • 00606959034365 ()
1120253

  • 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

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

DreamStation - 00606959043299

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

  • 00606959043299 ()
KRX200H15

  • Home CPAP unit

Dorma - 00606959038608

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

  • 00606959038608 ()
CNV207H

  • Heated respiratory humidifier
  • Home CPAP unit
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