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Evolve

FDA UDI

Class I (US FDA UDI)

by OriGen Biomedical, Inc.

Identity

Trade Name
Evolve FDA UDI
Generic Name
Blood/tissue storage/culture container FDA UDI
Device Name
120ml EVO cell culture bag, with female luers Additional, female to male tube accessory set 12cm in length FDA UDI
Model / Reference
EV120 + F-M12 FDA UDI
Description
120ml EVO cell culture bag, with female luers Additional, female to male tube accessory set 12cm in length FDA UDI

Identifiers

Primary DI / UDI-DI
10816203020090 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 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 624f93d0-d04f-4aba-9bc8-d1845bc5d1bc 34 fields · synced May 31, 2026