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4 x (21G Needle + 3C Patch® Needle Holder)
FDA UDIClass II (US FDA UDI)
by Reapplix ApS
Identity
- Trade Name
- 4 x (21G Needle + 3C Patch® Needle Holder) FDA UDI
- Generic Name
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
- Device Name
- This is the retail bag label for the retail bag, which contains 6 venipuncture needle sets (commercially available) and 6 3C Patch Needle Holders. FDA UDI
- Model / Reference
- 2 FDA UDI
- Description
- This is the retail bag label for the retail bag, which contains 6 venipuncture needle sets (commercially available) and 6 3C Patch Needle Holders. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05714188505206 FDA UDI
- FDA Product Code
- PMQ FDA UDI
- GMDN Term
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9245 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
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
No
FDA UDI
Category: Haematological concentrate system preparation kit, platelet concentration
4 x (21G Needle + 3C Patch® Needle Holder) by Reapplix ApS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Haematological concentrate system preparation kit, platelet concentration.
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Cleared under the same submission
BK200471 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
- Reapplix ApS
Sources (1)
- FDA UDI adf8bbd9-e21f-404b-9e77-d7c677fe4e60 35 fields · synced May 30, 2026