FDA UDI
In Commercial Distribution
🇺🇸 United States
Enbrel 25 mg/vial Multiple-use Vial
DI: 00358406425348
·
Model: 642534
·
AMGEN INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Enbrel 25 mg/vial Multiple-use Vial
- Primary DI
- 00358406425348
- Version / Model
- 642534
- Company Name
- AMGEN INC.
- Labeler DUNS
- 039976196
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-24
- Public Version
- 1
- Public Version Date
- 2019-11-01
- Public Version Status
- New
- Public Device Record Key
- adee0cb6-04c9-4be6-a760-406a195ca6e1
Device Description
Carton contents (4 dose trays, 1 package insert with attached Medication Guide and mixing date stickers) are intended to be dispensed as a unit. Each dose tray contains one 25 mg vial of etanercept, one diluent syringe (1 mL Sterile Bacteriostatic Water for Injection, USP, containing 0.9% benzyl alcohol), one 27 gauge 1/2 inch needle, one vial adapter, and one plunger.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- 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
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ONB | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | General Hospital | 880.5440 | 2 |
| FMF | Syringe, Piston | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41222 | Medication transfer set | A collection of sterile devices and supplies designed to transfer parenteral medications, and sometimes intravenous (IV) fluids, between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it may also be used to reconstitute medication for its preparation and administration. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10358406425345 | GS1 | Case | 8 | In Commercial Distribution | |
| Primary | 00358406425348 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 0.5 | Inch | |
| Needle Gauge | 27 | Gauge |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Once Enbrel multiple-dose vial has reached room temperature, do not put it back in the refrigerator.
- Type
- Special Storage Condition, Specify
- Special Conditions
- If needed, you may store your Enbrel multiple-dose vial and diluent syringe (dose tray) at room temperature between 68°F to 77°F (20°C to 25°C) for up to 14 days.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store Enbrel multiple-dose vial in the original carton to protect from light or physical damage.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Before and after reconstitution refrigerate. DO NOT FREEZE.
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius