AccessGUDID - DEVICE: LiveBand BFR (00850055775077)

GUDID

Device Identifier (DI) Information

Brand Name: LiveBand BFR
Version or Model: 3185-90007
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INNOVATION INSTITUTE, LLC

Primary DI Number: 00850055775077
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 027184489 *Terms of Use

Device Description: The LiveBand Blood Flow Restriction System is a portable and user-friendly Blood Flow Restriction device. BFR training is clinically proven to increase muscle strength and aid in physical and rehabilitation therapy, while reducing the weight load on joints. LiveBand BFR uses a proprietary system to actively manage and maintain the desired limb occlusion pressure, customized for each patient.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
14074	Surgical pneumatic tourniquet system	A device assembly intended to occlude the blood flow and to obtain a bloodless field during limb surgery or amputation. It typically consists of a pneumatic tourniquet cuff, a source of gas pressure used to inflate the cuff, and a control unit, i.e., a pressure indicator and regulator. By using a double cuff and a manual switching or automatic valve, the pressure point is regularly changed to avoid tissue damage or necrosis. The device will also typically include a timer or elapsed-time meter. It may also be used in combination with intravenous local anaesthesia to limit the area affected by the anaesthesia.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KCY	Tourniquet, Pneumatic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f47d45a1-32cd-4adc-b1a1-e485f8b43e95
Public Version Date: May 19, 2025
Public Version Number: 2
DI Record Publish Date: October 29, 2024