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B.braun

FDA UDI

Class I (US FDA UDI)

by B.Braun Avitum AG

Identity

Trade Name
B.BRAUN FDA UDI
Generic Name
Haemodialysis system, institutional FDA UDI
Device Name
Option WAN BSL Dialog+ SW 9 (7102231) FDA UDI
Model / Reference
7102231 FDA UDI
Description
Option WAN BSL Dialog+ SW 9 (7102231) FDA UDI

Identifiers

Catalog Number
7102231 FDA UDI
Primary DI / UDI-DI
04046963686758 FDA UDI
FDA Product Code
OUG FDA UDI
GMDN Term
Haemodialysis system, institutional FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6310 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

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Haemodialysis system, institutional

B.braun by B.Braun Avitum AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haemodialysis system, institutional.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
B.Braun Avitum AG

Sources (1)

  • FDA UDI f978e0fd-a3e6-46dc-942b-ab93d3af6491 36 fields · synced Jun 8, 2026