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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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Broadband Modem - 00606959028197

Broadband Oximetry Accessory, Japan
Respironics, Inc.
Broadband/Oximetry Accessory, JP
Not in Commercial Distribution

  • 00606959028197 ()
100225E

  • Clinical laboratory information system

Broadband - 00606959028180

Broadband Oximetry Accessory, USA
Respironics, Inc.
Broadband/Oximetry Accessory, US
Not in Commercial Distribution

  • 00606959028180 ()
100205E

  • Clinical laboratory information system

OmniLab Direct - 00606959044302

OmniLab Direct Software
Respironics, Inc.
OmniLab Direct Software - 2
In Commercial Distribution

  • 00606959044302 ()
1112033

  • Clinical laboratory information system

Omnilab Direct - 00606959044296

OmniLab Direct Software, Web
Respironics, Inc.
OmniLab Direct, Web Software - 2
In Commercial Distribution

  • 00606959044296 ()
1113127

  • Clinical laboratory information system

EverFlo Connect - 00606959044258

EverFlo Connect Module, US
Respironics, Inc.
EverFlo Connect Module, US
In Commercial Distribution

  • 00606959044258 ()
1128984

  • Clinical laboratory information system

System One - 00606959050754

System One Bluetooth Accessory Module, China
Respironics, Inc.
100240B
In Commercial Distribution

  • 00606959050754 ()
100240B

  • Clinical laboratory information system

DreamStation - 00606959058873

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

  • 00606959058873 ()
200602C

  • Clinical laboratory information system

DreamStation - 00606959058859

Cellular Modem with Oximetry, Canada
Respironics, Inc.
00
In Commercial Distribution

  • 00606959058859 ()
200601C

  • Clinical laboratory information system

DreamStation - 00606959058828

DreamStation Cellular Modem, Dipole, Europe
Respironics, Inc.
00
In Commercial Distribution

  • 00606959058828 ()
200625C

  • Clinical laboratory information system

DreamStation - 00606959058804

DreamStation Cellular Modem with Oximetry, Dipole, EU
Respironics, Inc.
00
In Commercial Distribution

  • 00606959058804 ()
200624C

  • Clinical laboratory information system

DreamStation - 00606959058224

DreamStation Cellular Modem, Device, South Korea
Respironics, Inc.
00
In Commercial Distribution

  • 00606959058224 ()
200675C

  • Clinical laboratory information system

DreamStation - 00606959058187

DreamStation WiFi Accessory, South Korea
Respironics, Inc.
00
In Commercial Distribution

  • 00606959058187 ()
100775W

  • Clinical laboratory information system

DreamStation - 00606959058170

DreamStation Cellular Modem with Oximetry, South Korea
Respironics, Inc.
01
In Commercial Distribution

  • 00606959058170 ()
100770W

  • Clinical laboratory information system

DreamStation - 00606959061132

DreamStation SpO2 Connection Module
Respironics, Inc.
DreamStation Spo2 Connection Module
In Commercial Distribution

  • 00606959061132 ()
1147056

  • Clinical laboratory information system

DreamStation - 00606959058200

DreamStation Cellular Modem, South Korea
Respironics, Inc.
00
In Commercial Distribution

  • 00606959058200 ()
100675C

  • Clinical laboratory information system

UDM (Urinalysis Data Manager) - 04987562488506

No Description
SYSMEX CORPORATION
1.X
In Commercial Distribution

  • 04987562488506 ()
AB364503

  • Clinical laboratory information system

Quantum ® - 05060434420039

Quantum Data Management Unit
SPECTRUM MEDICAL LIMITED
QDMU
Not in Commercial Distribution

  • 05060434420039 ()
3008-001-010

  • Patient health record information system

System M ® - 05060434420015

Data Management Monitor
SPECTRUM MEDICAL LIMITED
VIPER DM
Not in Commercial Distribution

  • 05060434420015 ()
3005-001-200

  • Patient health record information system

CENTRICITY PERINATAL - 00195278454386

MD CPN 6.99 MEDICAL DEVICE
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
6.99
In Commercial Distribution

  • 00195278454386 ()


  • Patient health record information system

Digital Expert Access - 00195278263919

DE Modality Connectivity Executable
GE HEALTHCARE
1
In Commercial Distribution

  • 00195278263919 ()


  • Diagnostic x-ray digital imaging system workstation
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