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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-13 FDA UDI
Description
Potassium chloride additive for bicarbonate dialysis. FDA UDI

Identifiers

Primary DI / UDI-DI
B637BAK131 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

The Di-Chem Hemodialysate Additive is a critical component in hemodialysis treatment, adding potassium chloride to bicarbonate dialysis solutions. This additive helps maintain physiological blood electrolyte and pH levels, promoting better patient outcomes. With its precise formulation and manufacturing process, this device ensures effective exchange of solutes while minimizing the risk of complications.

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 3596ef45-bc54-4faa-8831-266845bbcbf9 34 fields · synced Jul 14, 2026