Identity
- Trade Name
- ZYPREXA® Relprevv™ 210 mg Convenience Kit FDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Device Name
- Combination Drug/Device Convenience Kit: 1 - vial of Zyprexa Relprevv 210mg/vial (VL7635) 1 - 3 mL vial of Diluent 1 - 3 mL syringe w pre-attached Jelco 19-gauge 1.5 inch Hypodermic Needle-Pro need with needle protection device (EL31915 - GTIN 00351688072545) 2 - Jelco 19 gauge 1.5 inch Hypodermic Needle-Pro needles with needle protection device (EL1915 - GTIN 20351688075670) FDA UDI
- Model / Reference
- VL7635 FDA UDI
- Description
- Combination Drug/Device Convenience Kit: 1 - vial of Zyprexa Relprevv 210mg/vial (VL7635) 1 - 3 mL vial of Diluent 1 - 3 mL syringe w pre-attached Jelco 19-gauge 1.5 inch Hypodermic Needle-Pro need with needle protection device (EL31915 - GTIN 00351688072545) 2 - Jelco 19 gauge 1.5 inch Hypodermic Needle-Pro needles with needle protection device (EL1915 - GTIN 20351688075670) FDA UDI
Identifiers
- Catalog Number
- VL7635 FDA UDI
- Primary DI / UDI-DI
- 00300027635118 FDA UDI
- FDA Product Code
- FMI FDA UDI
- GMDN Term
- Hypodermic needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hypodermic needle, single-use
ZYPREXA® Relprevv™ 210 mg Convenience Kit by Eli Lilly And Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Eli Lilly And Company
Sources (1)
- FDA UDI da6cfabd-86e5-4298-b85b-4e4b1a90ec79 35 fields · synced May 30, 2026