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

  • 00606959050754 ()
100240B

  • Clinical laboratory information system
Cellular Modem, USA
Respironics, Inc.
Cellular Modem, US
Not in Commercial Distribution

  • 00606959049000 ()
200605C

  • Clinical laboratory information system
DreamStation Cellular Modem with Oximetry, Japan
Respironics, Inc.
DreamStation Cellular Modem with Oximetry, JP
Not in Commercial Distribution

  • 00606959048973 ()
100630C

  • Clinical laboratory information system
Software, HL7 Sleepware G3, Web
Respironics, Inc.
Software, HL7 Sleepware G3, Web - 3
In Commercial Distribution

  • 00606959048942 ()
1117948

  • Clinical laboratory information system
DreamStation WiFi Accessory with Oximetry, Australia
Respironics, Inc.
DreamStation Wi-Fi Accessory with Oximetry, AU
In Commercial Distribution

  • 00606959045873 ()
200740W

  • Clinical laboratory information system
DreamStation WiFi Accessory with Oximetry, EU
Respironics, Inc.
DreamStation Wi-Fi Accessory with Oximetry, EU
In Commercial Distribution

  • 00606959045866 ()
200721W

  • Clinical laboratory information system
DreamStation WiFi Accessory with Oximetry, US
Respironics, Inc.
DreamStation Wi-Fi Accessory with Oximetry, US
In Commercial Distribution

  • 00606959045859 ()
200700W

  • Clinical laboratory information system
DreamStation Cellular Modem with Oximetry, EU
Respironics, Inc.
DreamStation Cellular Modem with Oximetry, EU
Not in Commercial Distribution

  • 00606959045842 ()
200621C

  • Clinical laboratory information system
DreamStation Cellular Modem with Oximetry, US
Respironics, Inc.
DreamStation Cellular Modem with Oximetry, US
Not in Commercial Distribution

  • 00606959045835 ()
200600C

  • Clinical laboratory information system
Sentosa ST401i is used for emulsion PCR and forms part of SQ301 Platform.
VELA OPERATIONS SINGAPORE PTE. LTD.
400124
In Commercial Distribution

  • 08885013950069 ()
400124

  • Clinical laboratory information system
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