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GENIUS Blood and Marrow Concentration (BM/C) System

FDA UDI

Class II (US FDA UDI)

by Dsm Biomedical, Inc.

Identity

Trade Name
GENIUS Blood and Marrow Concentration (BM/C) System FDA UDI
Generic Name
Haematological concentrate system FDA UDI
Device Name
60mL Disposable Kit FDA UDI
Model / Reference
64150-04 FDA UDI
Description
60mL Disposable Kit FDA UDI

Identifiers

Catalog Number
G20060 FDA UDI
Primary DI / UDI-DI
M263G200600 FDA UDI
FDA Product Code
ORG FDA UDI
GMDN Term
Haematological concentrate system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.9245 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

Dimensions & Sizes

Size
Total Volume — 60 Microliter FDA UDI

Category: Haematological concentrate system

GENIUS Blood and Marrow Concentration (BM/C) System by Dsm Biomedical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haematological concentrate system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dsm Biomedical, Inc.

Sources (1)

  • FDA UDI fb0aabec-ad92-47e4-ba56-a10cc90c6244 35 fields · synced Jun 8, 2026