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3C Patch® Kit

FDA UDI

Class II (US FDA UDI)

by Reapplix ApS

Identity

Trade Name
3C Patch® Kit FDA UDI
Generic Name
Haematological concentrate system preparation kit, platelet concentration FDA UDI
Device Name
Kit that includes 3C Patch Device, 3C Patch Needle Holder, Venipuncture Needle Set (commercially available), Skin Preparation Alcohol Swab (commercially available), Post-Sampling Adhesive Bandage (band aid) (commercially available), and Primary Wound Cover Dressing (commercially available). FDA UDI
Model / Reference
1 FDA UDI
Description
Kit that includes 3C Patch Device, 3C Patch Needle Holder, Venipuncture Needle Set (commercially available), Skin Preparation Alcohol Swab (commercially available), Post-Sampling Adhesive Bandage (band aid) (commercially available), and Primary Wound Cover Dressing (commercially available). FDA UDI

Identifiers

Primary DI / UDI-DI
05714188505046 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

3C Patch® Kit 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 8f265d53-ca4d-4ef8-86be-bce2b97c5b6d 35 fields · synced May 30, 2026