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Venipuncture Needle and 3C Patch® Needle Holder - Extra Component Set

FDA UDI

Class II (US FDA UDI)

by Reapplix ApS

Identity

Trade Name
Venipuncture Needle and 3C Patch® Needle Holder - Extra Component Set FDA UDI
Generic Name
Haematological concentrate system preparation kit, platelet concentration FDA UDI
Device Name
This is the outer label for the box that contains 20 venipuncture needle sets (commercially available), 20 3C Patch Needle Holder, and the IFU. FDA UDI
Model / Reference
1 FDA UDI
Description
This is the outer label for the box that contains 20 venipuncture needle sets (commercially available), 20 3C Patch Needle Holder, and the IFU. FDA UDI

Identifiers

Primary DI / UDI-DI
05714188505220 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
Not 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

Venipuncture Needle and 3C Patch® Needle Holder - Extra Component Set by Reapplix ApS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Reapplix ApS

Sources (1)

  • FDA UDI 417762e9-1500-4425-a69c-20e036ae9d2b 35 fields · synced Jun 6, 2026