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B.braun

FDA UDI

Class II (US FDA UDI)

by B.Braun Avitum AG

Identity

Trade Name
B.BRAUN FDA UDI
Generic Name
Haemodialysis system, institutional FDA UDI
Device Name
Dialog+® Hemodialysis System Bicarbonate Cartridge Holder (BIC) FDA UDI
Model / Reference
7105171 FDA UDI
Description
Dialog+® Hemodialysis System Bicarbonate Cartridge Holder (BIC) FDA UDI

Identifiers

Catalog Number
7105171 FDA UDI
Primary DI / UDI-DI
04046963686697 FDA UDI
510(k) Number
K083460 FDA UDI
K963440 FDA UDI
FDA Product Code
KDI FDA UDI
GMDN Term
Haemodialysis system, institutional FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5860 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

No

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 II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haemodialysis system, institutional.

Cleared under the same submission

K083460 also covers:

K963440 also covers:

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 e3ecc890-ab3c-4b4a-a210-04a4c606d3f7 37 fields · synced May 30, 2026