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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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
ST401e is used for enrichment and forms part of SQ301 Platform.
VELA OPERATIONS SINGAPORE PTE. LTD.
400120
In Commercial Distribution

  • 08885013950076 ()
400120

  • 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
The Sentosa® SQ301 Platform is an in vitro diagnostic system composed of a sequencing instrument that measures the hydrogen ions that are generated during the incorporation of nucleotides in the DNA sequencing reaction and the ancillary instrumentation necessary for sample processing. This platform is used in conjunction with instrument-specific library preparation kits, template kits, sequencing kits, chip kits and data analysis software. The Sentosa® SQ301 Platform is intended for targeted sequencing of various biological samples. The Sentosa® SQ301 Platform is not intended for whole genome or de novo sequencing.
VELA OPERATIONS SINGAPORE PTE. LTD.
7468
In Commercial Distribution

  • 08885013950045 ()
400103

  • Clinical laboratory information system
Broadband Oximetry Accessory, International
Respironics, Inc.
Broadband/Oximetry Accessory, Intl
In Commercial Distribution

  • 00606959021570 ()
100215E

  • Clinical laboratory information system
OmniLab Connect System
Respironics, Inc.
OmniLab Connect System
In Commercial Distribution

  • 00606959021501 ()
1111076

  • Clinical laboratory information system
Broadband Accessory and WiFi Router, USA
Respironics, Inc.
Broadband Accessory and WiFi Router, US
In Commercial Distribution

  • 00606959013971 ()
100200E

  • Clinical laboratory information system
Bluetooth Accessory Module, International
Respironics, Inc.
Bluetooth Accessory Module, INTL
In Commercial Distribution

  • 00606959005143 ()
100220B

  • Clinical laboratory information system
Bluetooth Accessory Module, Canada
Respironics, Inc.
Bluetooth Accessory Module, CA
Not in Commercial Distribution

  • 00606959005136 ()
100210B

  • Clinical laboratory information system
Bluetooth Accessory Module, USA
Respironics, Inc.
Bluetooth Accessory Module, US
In Commercial Distribution

  • 00606959005129 ()
100200B

  • Clinical laboratory information system
PRI Cellular Modem, Japan
Respironics, Inc.
PRI Cellular Modem, JA
Not in Commercial Distribution

  • 00606959026704 ()
100230C

  • Clinical laboratory information system
PRI Cellular Modem, EU
Respironics, Inc.
PRI Cellular Modem, EU
In Commercial Distribution

  • 00606959026698 ()
100226C

  • Clinical laboratory information system
PRI Cellular Modem with PRI Label, EU
Respironics, Inc.
PRI Cellular Modem with PRI Label, EU
In Commercial Distribution

  • 00606959026681 ()
100224C

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

  • 00606959026674 ()
100204C

  • Clinical laboratory information system
DreamStation Cellular Modem, US
Respironics, Inc.
DreamStation Cellular Modem, US
In Commercial Distribution

  • 00606959023871 ()
100605C

  • Clinical laboratory information system
DreamStation Cellular Modem with Oximetry, USA
Respironics, Inc.
DreamStation Cellular Modem with Oximetry, US
In Commercial Distribution

  • 00606959022942 ()
100600C

  • Clinical laboratory information system
DreamStation Cellular Modem, Japan
Respironics, Inc.
00
In Commercial Distribution

  • 00606959022881 ()
100630C

  • 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 Cellular Modem with Oximetry, EU
Respironics, Inc.
DreamStation Cellular Modem with Oximetry, EU
Not in Commercial Distribution

  • 00606959045842 ()
200621C

  • Clinical laboratory information system
OmniLab Direct Software, Web
Respironics, Inc.
OmniLab Direct, Web Software - 2
In Commercial Distribution

  • 00606959044296 ()
1113127

  • Clinical laboratory information system
EverFlo Connect Module, US
Respironics, Inc.
EverFlo Connect Module, US
In Commercial Distribution

  • 00606959044258 ()
1128984

  • Clinical laboratory information system
OmniLab Connect System, Brazil
Respironics, Inc.
OmniLab Connect System, BR
Not in Commercial Distribution

  • 00606959043466 ()
BR1111076

  • Clinical laboratory information system
RJ9 to 2.5mm 3" Female Adapter Cable
Respironics, Inc.
RJ9 to 2.5mm 3" Female Adapter Cable
In Commercial Distribution

  • 00606959043244 ()
1080250

  • Clinical laboratory information system
RJ9 Nurse Call Cable - Open End
Respironics, Inc.
RJ9 Nurse Call Cable - Open End
In Commercial Distribution

  • 00606959043190 ()
1080249

  • Clinical laboratory information system
RJ9 to 1/4" Nurse Call Cable Alarm - Closed
Respironics, Inc.
RJ9 to 1/4" Nurse Call Cable Alarm - Closed
In Commercial Distribution

  • 00606959043176 ()
1080247

  • Clinical laboratory information system
DreamStation Cellular Modem Canada
Respironics, Inc.
00
In Commercial Distribution

  • 00606959058873 ()
200602C

  • Clinical laboratory information system
Cellular Modem with Oximetry, Canada
Respironics, Inc.
00
In Commercial Distribution

  • 00606959058859 ()
200601C

  • Clinical laboratory information system
DreamStation Cellular Modem, Dipole, Europe
Respironics, Inc.
00
In Commercial Distribution

  • 00606959058828 ()
200625C

  • Clinical laboratory information system
DreamStation Cellular Modem with Oximetry, Dipole, EU
Respironics, Inc.
00
In Commercial Distribution

  • 00606959058804 ()
200624C

  • Clinical laboratory information system
DreamStation Cellular Modem, Device, South Korea
Respironics, Inc.
00
In Commercial Distribution

  • 00606959058224 ()
200675C

  • Clinical laboratory information system
DreamStation Cellular Modem, South Korea
Respironics, Inc.
00
In Commercial Distribution

  • 00606959058200 ()
100675C

  • Clinical laboratory information system
DreamStation WiFi Accessory, South Korea
Respironics, Inc.
00
In Commercial Distribution

  • 00606959058187 ()
100775W

  • Clinical laboratory information system
DreamStation Cellular Modem with Oximetry, South Korea
Respironics, Inc.
01
In Commercial Distribution

  • 00606959058170 ()
100770W

  • Clinical laboratory information system
DreamStation SpO2 Connection Module
Respironics, Inc.
DreamStation Spo2 Connection Module
In Commercial Distribution

  • 00606959061132 ()
1147056

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

  • 00606959045859 ()
200700W

  • Clinical laboratory information system
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