H-Bandage Compression Dressing - Rolled
Basic Information
- Brand Name
- H-Bandage Compression Dressing - Rolled
- Primary DI
- 00857048006088
- Version / Model
- 1
- Catalog Number
- HB01
- 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
- 2
- Public Version Date
- 2022-02-21
- Public Version Status
- Update
- Public Device Record Key
- b59ff45b-0cef-4c70-8f6c-fc936bf49e5d
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
- 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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857048006088 | GS1 |