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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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10 Lead Burdick EKG, non-detachable Snaps
Advantage Medical Electronics, LLC
CB-721001R/2
In Commercial Distribution

  • 00849593011921 ()


  • Electrical-only medical device connection cable, reusable
AIO 3.0 Indexing Knob - Cranial for Belly & Pelvic Board
Orfit Industries NV
38107/2
In Commercial Distribution

  • 05420028735626 ()


  • Head/neck procedure positioner
Central Panel in HPL
Orfit Industries NV
35781-N1/2
In Commercial Distribution

  • 05420028717660 ()


  • DNA-based tissue typing IVD, reagent
Shim 2mm Head Acrylic Rev A
Orfit Industries NV
35702/2
In Commercial Distribution

  • 05420028713563 ()


  • DNA-based tissue typing IVD, reagent
Block 40mm in High Density rigid PE
Orfit Industries NV
35754/2
In Commercial Distribution

  • 05420028710951 ()


  • DNA-based tissue typing IVD, reagent
No Description
Neuroventis
2.x.x
In Commercial Distribution

  • 05419980275011 ()


  • Medication reminder application software
accessories for image enhancement in diagnostic displays
Barco NV
2.X.X.X
In Commercial Distribution

  • 05415334002050 ()
K9308260

  • Radiology picture archiving and communication system workstation
100% medical-grade silicone
CASCO BAY MOLDING LTD.
Mid 2
In Commercial Distribution

  • 00850004683422 ()


  • Menstrual cup, non-latex, reusable
MyNotifiRX: Is a Bluetooth wearable device that interacts with a patient’s smart phone via an app (iOS or android). All data is sent by wifi to a HIPAA controlled server for real time or accumulated time review by the provider. MyNotifiRX can be used to meet the rehabilitation needs of any extremity after injury. It can be used both pre and post-operatively to meet a patient’s rehabilitation needs. It is designed for acute or chronic use especially in patients at high risk for falls. As an added feature it is designed with a fall detection algorithm to alert designated care givers in the case of an emergency independent of a patient’s ability to respond. It is designed with two functions. 1) In patients who are evaluated to be at risk for falls, MyNotifi can act as a Fall protection device and monitor. It has a built in algorithm to detect when a possible fall occurs and alerts those that the wearer has designated that an issue has occurred. It is also imbedded with the OTAGO exercise protocol https://www.apta.org/PTinMotion/NewsNow/?blogid=10737418615&id=10737430053 ) which is clinically proven to help prevent falls by improving balance. Long term remote monitoring of patients to assist, adjust, advance or correct exercise regimen is possible. Even more important, it can serve as a means to catch early deterioration of function and signal the need for intervention before an accident occurs. 2) With its magnetic strip and extension band, it can be placed on any extremity to record an exercise regimen programmed by the provider. There is a library of over 40 APTA exercises (attach sheet) that can be selected. It is recommended for use in upper extremity patients for both nonoperative and post-operative rehabilitation. MyNotifi is best suited in the lower extremity for the rehab of non surgical patients. The addition of a monitor to measure heart rate and blood oxygenation during exercise adds to patient safety and serves as a measure of physical exertion during
MEDHAB, LLC
Version 2
In Commercial Distribution

  • 00850023296023 ()
MyNotifi RX - small

  • Bed/chair occupant movement pressure/vibration sensor
MyNotifiRX: Is a Bluetooth wearable device that interacts with a patient’s smart phone via an app (iOS or android). All data is sent by wifi to a HIPAA controlled server for real time or accumulated time review by the provider. MyNotifiRX can be used to meet the rehabilitation needs of any extremity after injury. It can be used both pre and post-operatively to meet a patient’s rehabilitation needs. It is designed for acute or chronic use especially in patients at high risk for falls. As an added feature it is designed with a fall detection algorithm to alert designated care givers in the case of an emergency independent of a patient’s ability to respond. It is designed with two functions. 1) In patients who are evaluated to be at risk for falls, MyNotifi can act as a Fall protection device and monitor. It has a built in algorithm to detect when a possible fall occurs and alerts those that the wearer has designated that an issue has occurred. It is also imbedded with the OTAGO exercise protocol https://www.apta.org/PTinMotion/NewsNow/?blogid=10737418615&id=10737430053 ) which is clinically proven to help prevent falls by improving balance. Long term remote monitoring of patients to assist, adjust, advance or correct exercise regimen is possible. Even more important, it can serve as a means to catch early deterioration of function and signal the need for intervention before an accident occurs. 2) With its magnetic strip and extension band, it can be placed on any extremity to record an exercise regimen programmed by the provider. There is a library of over 40 APTA exercises (attach sheet) that can be selected. It is recommended for use in upper extremity patients for both nonoperative and post-operative rehabilitation. MyNotifi is best suited in the lower extremity for the rehab of non surgical patients. The addition of a monitor to measure heart rate and blood oxygenation during exercise adds to patient safety and serves as a measure of physical exertion during
MEDHAB, LLC
Version 2
In Commercial Distribution

  • 00850023296016 ()
MyNotifi RX - medium

  • Bed/chair occupant movement pressure/vibration sensor
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