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Celling ART PRP System

FDA UDI

Class II (US FDA UDI)

by Celling Biosciences

Identity

Trade Name
Celling ART PRP System FDA UDI
Generic Name
Haematological concentrate system preparation kit, platelet concentration FDA UDI
Device Name
ART PRP 2-Step - this is a duplicate. see 1601-0001 - UDI# 00817771029174 FDA UDI
Model / Reference
1601-0001 FDA UDI
Description
ART PRP 2-Step - this is a duplicate. see 1601-0001 - UDI# 00817771029174 FDA UDI

Identifiers

Catalog Number
Duplicate See 000817771029174 FDA UDI
Primary DI / UDI-DI
00817771028887 FDA UDI
FDA Product Code
ORG 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

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

No

FDA UDI

Celling ART PRP System by Celling Biosciences — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

BK150221 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Celling Biosciences

Sources (1)

  • FDA UDI 36e68611-7eae-4587-a1d2-f9ee6fab90d1 37 fields · synced Jun 6, 2026