DriSate

FDA UDI

Class II (US FDA UDI)

by Rockwell Medical

Identity

Trade Name: DriSate FDA UDI
Generic Name: Haemodialysis concentrate FDA UDI
Model / Reference: DR-245 FDA UDI

Identifiers

Catalog Number: DR-245 FDA UDI
Primary DI / UDI-DI: 00814963020681 FDA UDI
510(k) Number: K981003 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

DriSate by Rockwell Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haemodialysis concentrate.

DIASOL — DIASOL INC · Class II
Hemo-Dial — EDLAW PHARMACEUTICALS, INC. · Class II
Di-Chem Hemodialysate Additive — Di-Chem, Incorporated · Class II
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

K981003 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Rockwell Medical

Sources (1)

FDA UDI 3a1d0739-adb3-4899-981d-6a2eb42a1fd5 34 fields · synced Jun 1, 2026