Duns Number:006421325
Device Description: Combination Drug/Device Convenience Kit: 1 - vial of Zyprexa Relprevv 405mg/vial (VL7637)1 Combination Drug/Device Convenience Kit: 1 - vial of Zyprexa Relprevv 405mg/vial (VL7637)1 - 3 mL vial of Diluent1 - 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)
Catalog Number
VL7637
Brand Name
ZYPREXA® Relprevv™ 405 mg Convenience Kit
Version/Model Number
VL7637
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMI
Product Code Name
Needle, Hypodermic, Single Lumen
Public Device Record Key
2ce16d93-eab2-4f01-bfb8-8b65adf2e6a9
Public Version Date
June 09, 2020
Public Version Number
1
DI Record Publish Date
June 01, 2020
Package DI Number
30300027637113
Quantity per Package
20
Contains DI Package
00300027637112
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |