30% Acetic Acid Solution

FDA UDI

Class II (US FDA UDI)

by Rockwell Medical

Identity

Trade Name: 30% Acetic Acid Solution FDA UDI
Generic Name: Haemodialysis concentrate FDA UDI
Model / Reference: R-300 FDA UDI

Identifiers

Catalog Number: R-300 FDA UDI
Primary DI / UDI-DI: 00814963021305 FDA UDI
510(k) Number: K954527 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Haemodialysis concentrate

30% Acetic Acid Solution by Rockwell Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haemodialysis concentrate.

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Hemo-Dial — EDLAW PHARMACEUTICALS, INC. · Class II
Centrisol Acid Concentrate — MEDIVATORS INC. · Class II
DIASOL — DIASOL INC · Class II
Centrisol Acid Concentrate — MEDIVATORS INC. · Class II
DIASOL — DIASOL INC · Class II

Cleared under the same submission

K954527 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Rockwell Medical

Sources (1)

FDA UDI bc9126c0-ce28-4d7b-8ebf-36befcf07e3e 34 fields · synced Jun 6, 2026