Identity
- Trade Name
- K-Pack II FDA UDI
- Generic Name
- Hypodermic needle, single-use FDA UDI
- Device Name
- K-Pack II Needle FDA UDI
- Model / Reference
- KN-2232RBB FDA UDI
- Description
- K-Pack II Needle FDA UDI
Identifiers
- Catalog Number
- KN-2232RBB FDA UDI
- Primary DI / UDI-DI
- 05413206211135 FDA UDI
- 510(k) Number
- K984576 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 22 Gauge FDA UDI
Category: Hypodermic needle, single-use
K-Pack II by Terumo Europe NV — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K984576 also covers:
- K-Pack II — Terumo Europe NV
- K-Pack II — Terumo Europe NV
- K-Pack II — Terumo Europe NV
- K-Pack II — Terumo Europe NV
- K-Pack II — Terumo Europe NV
- K-Pack II — Terumo Europe NV
- K-Pack II — Terumo Europe NV
- K-Pack II — Terumo Europe NV
- K-Pack II — Terumo Europe NV
- K-Pack II — Terumo Europe NV
- K-Pack II — Terumo Europe NV
- K-Pack II — Terumo Europe NV
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
- Terumo Europe NV
Sources (1)
- FDA UDI 0baea567-8bf8-46ba-8901-e40afccd0f4d 38 fields · synced May 30, 2026