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B Medical Systems

FDA UDI

Class II (US FDA UDI)

by B Medical Systems SARL

Identity

Trade Name
B Medical Systems FDA UDI
Generic Name
Blood refrigerator/freezer FDA UDI
Device Name
Blood refrigerator/ Plasma freezer FDA UDI
Model / Reference
BF261 FDA UDI
Description
Blood refrigerator/ Plasma freezer FDA UDI

Identifiers

Catalog Number
991.8346.** FDA UDI
Primary DI / UDI-DI
05450104548376 FDA UDI
FDA Product Code
KSE FDA UDI
GMDN Term
Blood refrigerator/freezer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.9700 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Blood refrigerator/freezer

B Medical Systems by B Medical Systems SARL — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blood refrigerator/freezer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
B Medical Systems SARL

Sources (1)

  • FDA UDI a40d3d3e-d4f7-4bcd-9ac6-b4534c4700c6 35 fields · synced Jun 8, 2026