AccessGUDID - DEVICE: Mini Compression Bandage (00857048006125)

GUDID

Device Identifier (DI) Information

Brand Name: Mini Compression Bandage
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HHMCB01
Company Name: H&H MEDICAL CORPORATION

Primary DI Number: 00857048006125
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 072656713 *Terms of Use

Device Description: Our smallest and thinnest trauma compression bandage, the Mini Compression Bandage provides the same emergency trauma capabilities as our Thin H bandage in a smaller, more versatile package. Manufactured with a 4 in x 6 in ABD pad, it’s vacuum-sealed and flat folded to be small enough to fit in a shirt vest or pant pocket. With our 4-foot proprietary elastic strap (stretched, 34 inches unstretched), the Mini Compression Bandage is strong enough to provide compression to wounds on any location.

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: 50e4eca0-4376-41d8-9058-9a51656df912
Public Version Date: February 03, 2023
Public Version Number: 2
DI Record Publish Date: July 10, 2020