Enbrel 25 Mg/vial Replacement
Each single-dose vial contains 25 mg (0.5 mL) of Enbrel.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Ande Healthcare Apparatus Co., Ltd. | Zibo | Shandong | Manufacturer | 7 |
Record
| Listed by | Amgen, Inc., United States |
|---|---|
| FDA product code | ONB |
| Device type | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| Record published | 2021-12-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Special storage condition: Keep Enbrel out of the reach of children; Special storage condition: Store Enbrel in the refrigerator between 36°F to 46°F (2°C to 8°C).; Special storage condition: Store the Enbrel single-dose vials at room temperature between 68°F to 77°F (20°C to 25°C) for up to 14 days. Throw away; Special storage condition: Do not shake; Special storage condition: Do not freeze or store in extreme heat or cold.; Special storage condition: Store Enbrel in the original carton to protect from light or damage. |
| Packaging | Case of 16 |
| Sizes | Length 0.5 in; needle gauge 27 G |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 642591 | Length 0.5 in | In distribution |
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Showing 12 of 60. All products under Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.