AXP Freezing Bag Set

FDA UDI

Class II (US FDA UDI)

by Thermogenesis Corp.

Identity

Trade Name: AXP Freezing Bag Set FDA UDI
Generic Name: Blood centrifugation system containment kit FDA UDI
Device Name: Freezing Bag Set FDA UDI
Model / Reference: 80135 FDA UDI
Description: Freezing Bag Set FDA UDI

Identifiers

Catalog Number: 80135 FDA UDI
Primary DI / UDI-DI: 00886368000292 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

Yes

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

FDA UDI

Category: Blood centrifugation system containment kit

AXP Freezing Bag Set 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

BK180198 also covers:

ThermoGenesis AXP — Thermogenesis Corp.

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 3eb10ccf-333f-4692-bf9d-fb20c99f73ce 36 fields · synced Jun 8, 2026