Identity
- Trade Name
- HumaPen® Luxura™ HD - SAMPLE FDA UDI
- Generic Name
- Empty self-injector, mechanical FDA UDI
- Device Name
- HumaPen Luxura HD is a reusable pen injector intended for use with Lilly 3 mL insulin cartridges. Designated for sample use. FDA UDI
- Model / Reference
- MS9675 FDA UDI
- Description
- HumaPen Luxura HD is a reusable pen injector intended for use with Lilly 3 mL insulin cartridges. Designated for sample use. FDA UDI
Identifiers
- Catalog Number
- MS9675 FDA UDI
- Primary DI / UDI-DI
- 00300029675013 FDA UDI
- 510(k) Number
- K100988 FDA UDI
- FDA Product Code
- FMF FDA UDI
- GMDN Term
- Empty self-injector, mechanical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Empty self-injector, mechanical
HumaPen® Luxura™ HD - SAMPLE by Eli Lilly And Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Empty self-injector, mechanical.
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- Omnitrope® Pen 10 — Sandoz Inc. · Class II
- InPen Smart Insulin System — COMPANION MEDICAL, INC. · Class II
- InPen — MEDTRONIC MINIMED, INC. · Class II
Cleared under the same submission
K100988 also covers:
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 316a786a-7683-486a-92fe-cbf5cfae6b68 36 fields · synced May 30, 2026