H&H Big Cinch Abdominal Bandage

Basic Information

• Brand Name: H&H Big Cinch Abdominal Bandage
• Primary DI: 00857048006064
• Version / Model: 1
• Catalog Number: BC01
• Company Name: H&H MEDICAL CORPORATION
• Labeler DUNS: 072656713
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-10
• Public Version: 3
• Public Version Date: 2023-02-03
• Public Version Status: Update
• Public Device Record Key: 15e4c9af-4611-4cd5-b677-e54079dc166d

Device Description

With a 12 in. x 16 in. ABD Pad capable of covering the largest wound areas, the Big Cinch protects vital abdominal organs and large wounds to keep them protected and provide hemorrhage control. The Big Cinch easily secures to the abdomen, leg, or other large area with over 5 feet of 4 in wide strengthened elastic wrap sewn onto the large ABD Pad. The pad and the wrap ensure a tight fit to to prevent slipping while gently protecting the delicate abdominal region. The Big Cinch comes in a sterile, vacuum-sealed 5 mil barrier bag, flat folded to create a small tight package.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FQM	Bandage, Elastic	General Hospital	880.5075	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857048006064	GS1