FDA UDI
In Commercial Distribution
🇺🇸 United States
First Aid Only
DI: 00092265911610
·
Model: 91161
·
Acme United Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- First Aid Only
- Primary DI
- 00092265911610
- Version / Model
- 91161
- Catalog Number
- 91161
- Company Name
- Acme United Corporation
- Labeler DUNS
- 001180207
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-25
- Public Version
- 2
- Public Version Date
- 2021-07-07
- Public Version Status
- Update
- Public Device Record Key
- 9bd91beb-0df0-4a69-ac1c-62669a82f80d
Device Description
Bleeding Control Cabinet meets Texas Mandate. Contains: Four Fabric Zippered Pouches, each containing: Windlass Tourniquet; Back-up Elastic Tourniquet; Hemostatic Blood-Clotting Gauze Pad, 4" x4"; Hema-Seal Trauma Dressing; Non-Vented Chest Seals (2); Aluminized Rescue/Shock Blanket; Trauma Pad Dressing, 5"x9"; Protective Nitrile Exam Gloves (2 pairs); Bandage Shears; Marker; Bleeding Control Product Usage Guidelines.
Device Characteristics
- Single Use
- No
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OHO | First Aid Kit Without Drug | General, Plastic Surgery | 878.4014 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44047 | First aid kit, non-medicated, single-use | A convenient collection of equipment and materials intended to be used in an emergency for the rapid, initial treatment of an injury. This device is typically used by emergency medical services (EMS), institutions, schools, the home, motor vehicles, and other public settings. This device does not contain medicinal substances/pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00092265911610 | GS1 |
Customer Contacts
- Phone
- 800-835-2263
- [email protected]