Duns Number:006421325
Device Description: HumaPen Luxura HD is a reusable pen injector intended for use with Lilly 3 mL insulin cart HumaPen Luxura HD is a reusable pen injector intended for use with Lilly 3 mL insulin cartridges.
Catalog Number
MS9673
Brand Name
HumaPen® Luxura™ HD
Version/Model Number
MS9673
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"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K100988,K100988
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
7c4a671a-8c83-4764-bf12-20c3e8f01451
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 21, 2016
Package DI Number
30300029673010
Quantity per Package
25
Contains DI Package
00300029673019
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 |