AccessGUDID - DEVICE: H-Bandage Compression Dressing

GUDID

Device Identifier (DI) Information

Brand Name: H-Bandage Compression Dressing - Rolled
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HB01
Company Name: H&H MEDICAL CORPORATION

Primary DI Number: 00857048006088
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 072656713 *Terms of Use

Device Description: The H-Bandage is the latest in Universal Severe Trauma Dressings. An upgrade to our patented combat dressing Cinch Tight, the H-Bandage gives medics and field personnel both an emergency dressing and a hemostat for arterial bleeding and hemorrhaging in limbs. The H-Bandage’s unique design allows for one-handed use under any condition. Designed for First Responders, Military, and Law Enforcement, the H-Bandage provides a fast, effective tool for all kinds of serious traumas and injuries involving arterial bleeding. The unique design of the H-Bandage, with its 8 in thick ABD pad and the unique 5 foot elastic wrap designed for both strength and flexibility along with the H-shaped cinch sewn into the bandage, allows it to satisfy multiple field needs. The H-shaped cinch allows for direct pressure to be applied directly on top of a wound, increasing compression and reducing blood loss.

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":	Yes
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?
47011	First aid absorbent pad/bandage	A wound cover intended to be used as an initial, short-term treatment after injury that consists of an absorbent pad (e.g., gauze, cotton wool, lint, cellulose) that is attached to a roll bandage (e.g., cotton or cotton/viscose). The pad is applied directly to the wound, and the bandage is subsequently wrapped around the pad and secured. The device is intended for use in the home or a clinical setting to protect wounds, arrest bleeding, and introduce medications placed on the pad. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FQM	Bandage, Elastic

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: Yes
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: b59ff45b-0cef-4c70-8f6c-fc936bf49e5d
Public Version Date: February 21, 2022
Public Version Number: 2
DI Record Publish Date: July 10, 2020