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Bicarby

FDA UDI

Class II (US FDA UDI)

by Fresenius Medical Care Renal Therapies Group, LLC

Identity

Trade Name
Bicarby FDA UDI
Generic Name
Haemodialysis dialysate solution FDA UDI
Device Name
Bicarby Dialysate RFP-456 FDA UDI
Model / Reference
RFP-456-G FDA UDI
Description
Bicarby Dialysate RFP-456 FDA UDI

Identifiers

Primary DI / UDI-DI
00840861102945 FDA UDI
510(k) Number
K243786 FDA UDI
FDA Product Code
KPO FDA UDI
GMDN Term
Haemodialysis dialysate solution 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

Yes

FDA UDI

Single Use

Yes

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Total Volume — 5000 Milliliter FDA UDI

Category: Haemodialysis dialysate solution

Bicarby by Fresenius Medical Care Renal Therapies Group, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haemodialysis dialysate solution.

Cleared under the same submission

K243786 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fresenius Medical Care Renal Therapies Group, LLC

Sources (1)

  • FDA UDI 63dbee42-2bea-42d2-9ee0-301f3f7883a8 36 fields · synced May 30, 2026