Thermogenesis Start Up Accessory Kit, MarrowXpress

FDA UDI

Class I (US FDA UDI)

by Thermogenesis Corp.

Identity

Trade Name: Thermogenesis Start Up Accessory Kit, MarrowXpress FDA UDI
Generic Name: Blood centrifugation system containment kit FDA UDI
Device Name: Thermogenesis Start Up Accessory Kit, MarrowXpress FDA UDI
Model / Reference: 8-5142 FDA UDI
Description: Thermogenesis Start Up Accessory Kit, MarrowXpress FDA UDI

Identifiers

Primary DI / UDI-DI: 00886368000551 FDA UDI
510(k) Number: K081345 FDA UDI
FDA Product Code: JQC FDA UDI
GMDN Term: Blood centrifugation system containment kit 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Blood centrifugation system containment kit

Thermogenesis Start Up Accessory Kit, MarrowXpress 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 25116d3c-a832-41ab-a598-06bb9fe26348 36 fields · synced May 30, 2026