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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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Orpyx Hub - 10185571000554

The Orpyx Hub is the bluetooth-cellular bridge that enables sensor data from the insole to be sent to the cloud as part of the Orpyx Customer Sensory Insole System. This package contains a replacement Orpyx Hub and product documentation such as a manual. The Orpyx Custom Sensory Insole system consists of a powered limb overload warning technology to provide real time notifications for pressure offloading. For wellness purposes the system also includes temperature sensors to monitor physiological parameters such as plantar foot skin temperature and motion sensors to measure activity. The Orpyx Custom Sensory Insole is fabricated from a foot impression. The Orpyx Custom Sensory Insole system is intended to act as an adjunct to standard footcare, not a replacement. It is designed for use throughout everyday activities. Orpyx Sensory Insoles system is indicated for people at risk of developing ulcers on the plantar aspect of the foot. The device is a prescription device and is not transferable to another person. The product does not diagnose or treat any conditions, it is meant to be used as an adjunct to current foot care practices.
Orpyx
OH000010
In Commercial Distribution

  • 10185571000554 ()


  • Medical networking interface unit

SJM CONFIRM™ - 05414734502696

External Patient Activator
ST. JUDE MEDICAL, INC.
DM2100A
In Commercial Distribution

  • 05414734502696 ()
DM2100A

  • Implantable cardiac monitor programmer/transmitter/alarm

Active Breathing Coordinator - 05060191071284

Control Module, Active Breathing Coordinator
ELEKTA LIMITED
1528859
In Commercial Distribution

  • 05060191071284 ()


  • Real-time position management respiratory gating system, optical

Active Breathing Coordinator - 05060191071277

Active Breathing Coordinator
ELEKTA LIMITED
1504204
In Commercial Distribution

  • 05060191071277 ()


  • Real-time position management respiratory gating system, optical

E-LINK EX2 Interface Unit for M400 - 05060481692465

The EX2 Interface Unit is used to connect the M400 Myo-EX (GX1, GX2) and AngleX (NC1, NC2) sensors to E3000 Serial Interface Upper Limb Exerciser. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13
BIOMETRICS LIMITED
EX2
In Commercial Distribution

  • 05060481692465 ()


  • Medical networking interface unit

DataLITE AD2 Wireless Adaptor - 05060481690621

The DataLITE AD2 Adaptor is used with the DataLITE DG2 Dongle to readily interface the following devices: Dynamometer, MyoMeter, Pinchmeter, ForcePlates and Load Cells.This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013
BIOMETRICS LIMITED
AD2
In Commercial Distribution

  • 05060481690621 ()


  • Medical networking interface unit

DataLITE CA2 Battery Charger - 05060481690614

Mains powered battery charging unit for up to 8 wireless DataLITE sensors (LE230, W series Goniometers, Z series Torsiometers, AD2, ACL500). Includes Medical Grade Power Supply and country specific mains power cord..This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013
BIOMETRICS LIMITED
CA2
In Commercial Distribution

  • 05060481690614 ()


  • Medical networking interface unit

DataLITE DG2 Wireless Dongle - 05060481690607

A small wireless Dongle (receiver) attached to the USB port of the host PC (Windows 8 or 10 compatible) can communicate with up to 24 channels of DataLITE sensor inputs via Wi-Fi. When used with a Windows 10 Tablet, the researcher can monitor and analyse data in real-time while the subject has total freedom of movement in laboratory or field studies.This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013
BIOMETRICS LIMITED
DG2
In Commercial Distribution

  • 05060481690607 ()


  • Medical networking interface unit

E-LINK X4 Interface Unit - 05060481690492

The X4 InterX Unit functions as the intelligent interface to connect the E-LINK evaluation and exercise modules to the computer via the USB port. Up to four E-LINK devices may be connected simultaneously allowing the user to easily and quickly switch between them during an evaluation or exercise session. Includes Medical Grade Power Supply and country specific mains power cord. This product is independently tested and certified to EN 60601-1:1990 including Amendments A1, A2 and A13
BIOMETRICS LIMITED
X4
In Commercial Distribution

  • 05060481690492 ()
X4 MkII metal connectors

  • Medical networking interface unit

E-LINK AD1 Wireless Adaptor - 05060481690218

The AD1 wireless Adaptor which can be used with various E-LINK devices – Dynamometer, Pinchmeter, Goniometers, ForcePlate and the Upper Limb Exerciser.This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013
BIOMETRICS LIMITED
AD1
In Commercial Distribution

  • 05060481690218 ()


  • Medical networking interface unit
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