FDA UDI
In Commercial Distribution
🇺🇸 United States
AutoTouch reusable autoinjector
DI: 00358406470010
·
Model: 9003600
·
AMGEN INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- AutoTouch reusable autoinjector
- Primary DI
- 00358406470010
- Version / Model
- 9003600
- Company Name
- AMGEN INC.
- Labeler DUNS
- 039976196
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-24
- Public Version
- 1
- Public Version Date
- 2019-10-02
- Public Version Status
- New
- Public Device Record Key
- f9d908e5-7c28-4cdb-bb25-002f83ac2c0e
Device Description
AutoTouch reusable autoinjector for use with Enbrel Mini (etanercept) single-dose prefilled cartridge
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NSC | Injector, Pen | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45771 | Cartridge-accepting autoinjector, mechanical | A portable, hand-held, mechanical device, typically in the form of a large pen, designed to accept a pharmaceutical-containing cartridge (not included) and intended to be used by a patient to subcutaneously inject a dose of the pharmaceutical agent via a replaceable needle. The cartridge is inserted into the device and typically a dial on the device is operated for dosing (e.g., via a spring-loaded mechanism); the cartridge is replaced once the pharmaceutical is exhausted. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10358406470017 | GS1 | Case | 15 | In Commercial Distribution | |
| Primary | 00358406470010 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry