First Aid Only
- Primary DI
- 00092265060158
- Brand
- First Aid Only
- Company
- Acme United Corporation
- Model
- FAE-6015
- Catalog number
- FAE-6015
- Device description
- Smart Compliance box First aid CPR mask and 1 pair of gloves
- Published
- 2022-01-17
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- true
- Sterile
- false
- Single use
- true
Related Records
Contact Domains
acmeunited.comProduct Codes
| Code | Name |
|---|---|
| OHO | First Aid Kit Without Drug |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| OHO | First Aid Kit Without Drug | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00092265060158 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00092265060158 | 00092265060158 | 092265060158 | 0092265060158 |
GMDN Terms
| Term | Definition |
|---|---|
| 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. |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| 800-835-2263 | customerservice@acmeunited.com |
Regulatory Flags
- DUNS number
- 001180207
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- false
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00738743210119 | First Aid Only | 21-011 | 21-011 | 2022-12-15 |
| 00738743961424 | Elite First Aid | 96142 | 96142 | 2025-06-12 |
| 00738743961431 | Elite First Aid | 96143 | 96143 | 2025-06-12 |
| 00738743007030 | First Aid Only | M284-400 | M284-400 | 2023-01-06 |
| 00092265912617 | First Aid Only | 91261 | 91261 | 2023-07-21 |
| 00092265913898 | First Aid Only | 91389 | 91389 | 2022-09-09 |
| 00092265913904 | First Aid Only | 91390 | 91390 | 2022-09-09 |
| 00092265913911 | First Aid Only | 91391 | 91391 | 2022-09-09 |
| 00092265913928 | First Aid Only | 91392 | 91392 | 2022-09-09 |
| 00092265913935 | First Aid Only | 91393 | 91393 | 2022-09-09 |
| 00092265913980 | First Aid Only | 91398 | 91398 | 2022-09-09 |
| 00092265914024 | First Aid Only | 91402 | 91402 | 2022-09-09 |
| 00092265914031 | First Aid Only | 91403 | 91403 | 2022-09-09 |
| 00092265914048 | First Aid Only | 91404 | 91404 | 2022-09-09 |
| 00092265914055 | First Aid Only | 91405 | 91405 | 2022-09-09 |
| 00738743002608 | First Aid Only | 36693CV | 36693CV | 2022-09-09 |
| 00738743002721 | First Aid Only | 501171 | 501171 | 2022-09-09 |
| 00738743006507 | First Aid Only | DX0401M | DX0401M | 2022-09-09 |
| 00092265913256 | First Aid Only | 91325 | 91325 | 2022-08-26 |
| 00092265913263 | First Aid Only | 91326 | 91326 | 2022-08-26 |
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