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PermaLife™ Cell Culture Bag

FDA UDI

Class U (US FDA UDI)

by OriGen Biomedical, Inc.

Identity

Trade Name
PermaLife™ Cell Culture Bag FDA UDI
Generic Name
Blood/tissue storage/culture container FDA UDI
Device Name
PermaLife Cell Culture Bag, 7 mL - no green vent capx FDA UDI
Model / Reference
PL07-2G FDA UDI
Description
PermaLife Cell Culture Bag, 7 mL - no green vent capx FDA UDI

Identifiers

Catalog Number
PL07-2G FDA UDI
Primary DI / UDI-DI
10816203023923 FDA UDI
510(k) Number
K021702 FDA UDI
FDA Product Code
LPZ FDA UDI
GMDN Term
Blood/tissue storage/culture container FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
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

Category: Blood/tissue storage/culture container

PermaLife™ Cell Culture Bag by OriGen Biomedical, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blood/tissue storage/culture container.

Cleared under the same submission

K021702 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 b73f384e-3cec-4ec1-bbf7-cb01377bbc50 37 fields · synced May 30, 2026