3D Bag Set

FDA UDI

Class I (US FDA UDI)

by Thermogenesis Corp.

Identity

Trade Name: 3D Bag Set FDA UDI
Generic Name: Cryobiological storage container FDA UDI
Device Name: 3D Bag Set FDA UDI
Model / Reference: 80105 FDA UDI
Description: 3D Bag Set FDA UDI

Identifiers

Primary DI / UDI-DI: 00886368000148 FDA UDI
FDA Product Code: LXG FDA UDI
GMDN Term: Cryobiological storage container FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.2050 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Category: Cryobiological storage container

3D Bag Set by Thermogenesis Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Thermogenesis Corp.

Sources (1)

FDA UDI 536a33bc-0029-4243-96c4-5103ed9dc618 35 fields · synced May 31, 2026