Pxp

FDA UDI

Class II (US FDA UDI)

by Thermogenesis Corp.

Identity

Trade Name: PXP FDA UDI
Generic Name: Blood centrifugation system containment kit FDA UDI
Device Name: PXP Disposable Cartridge FDA UDI
Model / Reference: 80088 FDA UDI
Description: PXP Disposable Cartridge FDA UDI

Identifiers

Primary DI / UDI-DI: 00886368000971 FDA UDI
FDA Product Code: OAO FDA UDI
GMDN Term: Blood centrifugation system containment kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.9900 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Category: Blood centrifugation system containment kit

Pxp by Thermogenesis Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Stem Cell Banking-Single-use kits — Biosafe S.A. · Class II

Cleared under the same submission

BK120061 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: Thermogenesis Corp.

Sources (1)

FDA UDI 7490e373-3cb6-41a0-8f07-875be615bb1b 36 fields · synced Jun 8, 2026