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Cryostore

FDA UDI

Class II (US FDA UDI)

by OriGen Biomedical, Inc.

Identity

Trade Name
Cryostore FDA UDI
Generic Name
Blood/tissue storage/culture container FDA UDI
Device Name
Cryostore 500 EVA Bag, custom-width, N-tube set, in custom-width O-Wrap, case of 12 FDA UDI
Model / Reference
CS500i2PW FDA UDI
Description
Cryostore 500 EVA Bag, custom-width, N-tube set, in custom-width O-Wrap, case of 12 FDA UDI

Identifiers

Primary DI / UDI-DI
10816203021196 FDA UDI
FDA Product Code
KSR FDA UDI
GMDN Term
Blood/tissue storage/culture container FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.9100 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

Cryostore by OriGen Biomedical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

BK030036 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
OriGen Biomedical, Inc.

Sources (1)

  • FDA UDI 7c810fac-27e3-4704-98de-d9c09ed8c3d3 36 fields · synced Jun 1, 2026