FDA UDI
In Commercial Distribution
🇺🇸 United States
BATTLE BANDAGE
DI: M68932700010
·
Model: 01
·
Safeguard US Operating, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BATTLE BANDAGE
- Primary DI
- M68932700010
- Version / Model
- 01
- Catalog Number
- 32-700
- Company Name
- Safeguard US Operating, LLC
- Labeler DUNS
- 118492643
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-07
- Public Version
- 4
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- 7caad68c-a331-40bf-86f2-b955e6c8dd8c
- Distribution End Date
- 2024-08-07
Device Description
Battle Bandage 1 ea - 8" x 8" sterile gauze pad with 6' x 4" clear, self adhering, compression wrap
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- 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 |
|---|---|---|---|---|
| MHW | Dressing, Compression | General Hospital | 880.5075 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62744 | Wound dressing kit, non-medicated | A collection of instruments and dressings intended to be used to dress a wound. Items typically include scissors, forceps, gauze, and cotton-tip applicators; it does not contain a pharmaceutical. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M68932700010 | HIBCC |