AccessGUDID - DEVICE: B-COOL KNEE IMMOB 20" W/POCKETS (00840314812339)

GUDID

Device Identifier (DI) Information

Brand Name: B-COOL KNEE IMMOB 20" W/POCKETS
Version or Model: HM2642
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Hausmann Enterprises, LLC

Primary DI Number: 00840314812339
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001892660 *Terms of Use

Device Description: B-COOL KNEE IMMOB 20" W/POCKETS SKU HM2642

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
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?
56282	Knee support/thermal therapy bandage	A non-sterile fabric material formed to fit around the knee and intended to provide pressure to support the joint following injury (e.g., sports injuries), disease (e.g., rheumatism), and/or surgery; it is designed to accommodate the insertion of a hot/cold pack(s) to provide heat or cold therapy for the skin and underlying tissues to facilitate the reduction of oedema and pain. The device typically includes fasteners; it may be used in a healthcare facility or at home. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITQ	Joint, Knee, External Brace

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: 0de8814a-5939-43a0-a064-fbc0afe6f8da
Public Version Date: February 10, 2025
Public Version Number: 1
DI Record Publish Date: January 31, 2025