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AmeriWater 00BC100-100 Bicarb Mix and Distribution System

FDA UDI

Class II (US FDA UDI)

by Ameriwater Llc.

Identity

Trade Name
AmeriWater 00BC100-100 Bicarb Mix and Distribution System FDA UDI
Generic Name
Haemodialysis bicarbonate solution preparation mixer FDA UDI
Device Name
Dual Tank Bicarb Mix and Distribution System, 100 Gallon FDA UDI
Model / Reference
00BC100-100 FDA UDI
Description
Dual Tank Bicarb Mix and Distribution System, 100 Gallon FDA UDI

Identifiers

Primary DI / UDI-DI
00817927020062 FDA UDI
510(k) Number
K051031 FDA UDI
FDA Product Code
FIN FDA UDI
GMDN Term
Haemodialysis bicarbonate solution preparation mixer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5820 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 bicarbonate solution preparation mixer

AmeriWater 00BC100-100 Bicarb Mix and Distribution System by Ameriwater Llc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haemodialysis bicarbonate solution preparation mixer.

Cleared under the same submission

K051031 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ameriwater Llc.

Sources (1)

  • FDA UDI 095c06cd-a567-43fa-9aae-02fc055dbdfe 34 fields · synced Jun 1, 2026