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Aquaboss®

FDA UDI

Class II (US FDA UDI)

by B.Braun Avitum AG

Identity

Trade Name
Aquaboss® FDA UDI
Generic Name
Haemodialysis water purification system washer-disinfector (thermal) FDA UDI
Device Name
HOT RINSE SMART 20 FDA UDI
Model / Reference
LA2050421 FDA UDI
Description
HOT RINSE SMART 20 FDA UDI

Identifiers

Catalog Number
LA2050421 FDA UDI
Primary DI / UDI-DI
04046964843037 FDA UDI
FDA Product Code
FIP FDA UDI
GMDN Term
Haemodialysis water purification system washer-disinfector (thermal) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5665 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Haemodialysis water purification system washer-disinfector (thermal)

Aquaboss® by B.Braun Avitum AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haemodialysis water purification system washer-disinfector (thermal).

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 d9829726-00ab-4069-b353-f5597ee08982 36 fields · synced May 30, 2026