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Evolve Cell Culture Bag

FDA UDI

Class I (US FDA UDI)

by OriGen Biomedical, Inc.

Identity

Trade Name
Evolve Cell Culture Bag FDA UDI
Generic Name
Blood/tissue storage/culture container FDA UDI
Device Name
EVO Bag, 70-120ml Fill Volume, with luer connections and needle free valve with separate female to male tube set with 12cm of tubing FDA UDI
Model / Reference
EV120 + F-M12 FDA UDI
Description
EVO Bag, 70-120ml Fill Volume, with luer connections and needle free valve with separate female to male tube set with 12cm of tubing FDA UDI

Identifiers

Catalog Number
EV120 + F-M12 FDA UDI
Primary DI / UDI-DI
10816203024074 FDA UDI
FDA Product Code
KJA FDA UDI
GMDN Term
Blood/tissue storage/culture container FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.2240 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

Yes

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

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

Similar devices

Also classified as Blood/tissue storage/culture container.

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 29d4e357-acd2-4f4e-9932-672b9623d5c8 36 fields · synced May 30, 2026