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Di-Chem Hemodialysate Additive

FDA UDI

Class II (US FDA UDI)

by Di-Chem, Incorporated

Identity

Trade Name
Di-Chem Hemodialysate Additive FDA UDI
Generic Name
Haemodialysis concentrate FDA UDI
Device Name
Potassium chloride additive for bicarbonate dialysis. FDA UDI
Model / Reference
BAK-902 FDA UDI
Description
Potassium chloride additive for bicarbonate dialysis. FDA UDI

Identifiers

Primary DI / UDI-DI
B637BAK9021 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

Di-Chem Hemodialysate Additive by Di-Chem, Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haemodialysis concentrate.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Di-Chem, Incorporated

Sources (1)

  • FDA UDI 4305cc92-6d00-411b-b721-7e8d39b7c528 34 fields · synced May 31, 2026