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MedicaLyte

FDA UDI

Class II (US FDA UDI)

by Dimesol Usa, Llc

Identity

Trade Name
MedicaLyte FDA UDI
Generic Name
Haemodialysis concentrate FDA UDI
Device Name
Liquid Bicarbonate Concentrate FDA UDI
Model / Reference
BC-201 FDA UDI
Description
Liquid Bicarbonate Concentrate FDA UDI

Identifiers

Primary DI / UDI-DI
00817411020257 FDA UDI
510(k) Number
K012547 FDA UDI
FDA Product Code
KPO FDA UDI
GMDN Term
Haemodialysis concentrate 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

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

No

FDA UDI

Category: Haemodialysis concentrate

MedicaLyte by Dimesol Usa, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haemodialysis concentrate.

Cleared under the same submission

K012547 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dimesol Usa, Llc

Sources (1)

  • FDA UDI bce97b75-ccde-4e11-8363-61c44b01dbb0 34 fields · synced May 30, 2026