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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 - 00606959022942

DreamStation Cellular Modem with Oximetry, USA
Respironics, Inc.
DreamStation Cellular Modem with Oximetry, US
In Commercial Distribution

  • 00606959022942 ()
100600C

  • Clinical laboratory information system

DreamStation - 00606959022881

DreamStation Cellular Modem, Japan
Respironics, Inc.
00
In Commercial Distribution

  • 00606959022881 ()
100630C

  • Clinical laboratory information system

Broadband - 00606959021570

Broadband Oximetry Accessory, International
Respironics, Inc.
Broadband/Oximetry Accessory, Intl
In Commercial Distribution

  • 00606959021570 ()
100215E

  • Clinical laboratory information system

OmniLab Connect - 00606959021501

OmniLab Connect System
Respironics, Inc.
OmniLab Connect System
In Commercial Distribution

  • 00606959021501 ()
1111076

  • Clinical laboratory information system

Broadband - 00606959013971

Broadband Accessory and WiFi Router, USA
Respironics, Inc.
Broadband Accessory and WiFi Router, US
In Commercial Distribution

  • 00606959013971 ()
100200E

  • Clinical laboratory information system

Bluetooth - 00606959005143

Bluetooth Accessory Module, International
Respironics, Inc.
Bluetooth Accessory Module, INTL
In Commercial Distribution

  • 00606959005143 ()
100220B

  • Clinical laboratory information system

Bluetooth - 00606959005136

Bluetooth Accessory Module, Canada
Respironics, Inc.
Bluetooth Accessory Module, CA
Not in Commercial Distribution

  • 00606959005136 ()
100210B

  • Clinical laboratory information system

Bluetooth - 00606959005129

Bluetooth Accessory Module, USA
Respironics, Inc.
Bluetooth Accessory Module, US
In Commercial Distribution

  • 00606959005129 ()
100200B

  • Clinical laboratory information system

PTS Connect™ Universal Solution - 00381933771015

The PTS Connect™ Universal Solution offers the ability to connect wired and wireless PTS Diagnostics analyzers to the PTS Connect Universal Solution. The PTS Connect Universal Solution will collect test results from the connected devices, generate patient results, and allow the user to export data.
POLYMER TECHNOLOGY SYSTEMS, INC.
3771
In Commercial Distribution

  • 00381933771015 ()
3771

  • Clinical laboratory information system

OR Barcode Scanner - 00850015699016

After the surgery is completed, the OR Barcode Scanner can be used to scan the barcodes on the labels of the CTE and other implanted TKA components.
Canary Medical USA LLC
43-5570-006-14
In Commercial Distribution

  • 00850015699016 ()


  • Patient health record information system
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