AccessGUDID - DEVICE: Thin H Compression Dressing, Flat Fold (00857048006118)

GUDID

Device Identifier (DI) Information

Brand Name: Thin H Compression Dressing, Flat Fold
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HBTF
Company Name: H&H MEDICAL CORPORATION

Primary DI Number: 00857048006118
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 072656713 *Terms of Use

Device Description: Based on the proven design of the H-Bandage compression dressing, the Thin H Bandage combines a 4" x 7.5" thick ABD pad with a strong elastic strap and the patented H-cleat compression device. The H-cleat allows first responders to deliver pressure down onto a wound to control bleeding and protect the wounded area. The H&H Thin H comes in a sterile, vacuum-sealed 5 mil barrier bag, in either a flat fold or a standard fold to create a small tight package. This gives users choices regarding which version to pack in their kit. The Thin H is popular in small kits, small vacuum-sealed packs, and as a stand-alone product.

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?
47976	Femoral artery compression bandage, single-use	A stretchable piece of fabric material intended to provide pressure for haemostasis to a punctured site on a patient having undergone femoral artery catheterization. It can be used as an alternative to direct hand pressure. This device may be T-shaped and constructed to wrap tightly around the patient's hips/thigh typically with a pressure point device inserted beneath it to augment compression. It is typically used following coronary angiography/ventriculography and percutaneous transluminal coronary angioplasty (PTCA); it may be used on brachial and radial arteries or after venipuncture. 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: c2bf2b0e-f5c9-45e8-9f20-244c9c081518
Public Version Date: February 03, 2023
Public Version Number: 2
DI Record Publish Date: July 10, 2020