FDA UDI
In Commercial Distribution
🇺🇸 United States
Thin H Compression Bandage, Standard Fold
DI: 00857048006101
·
Model: 1
·
H&H MEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Thin H Compression Bandage, Standard Fold
- Primary DI
- 00857048006101
- Version / Model
- 1
- Catalog Number
- HBT01
- 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
- 2023-02-03
- Public Version Status
- Update
- Public Device Record Key
- 19dc77ce-70b1-4ab6-9b34-cfbe9042211b
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
- 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 |
|---|---|---|---|---|
| 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 | 00857048006101 | GS1 |