← Back to catalogue

BiPro Bicarb Mixing/Distribution System

FDA UDI

Class II (US FDA UDI)

by Medical Solutions International

Identity

Trade Name
BiPro Bicarb Mixing/Distribution System FDA UDI
Generic Name
Haemodialysis bicarbonate solution preparation mixer FDA UDI
Model / Reference
SDS-CB200 FDA UDI

Identifiers

Primary DI / UDI-DI
B285SDSCB2001 FDA UDI
510(k) Number
K033118 FDA UDI
FDA Product Code
FIN FDA UDI
GMDN Term
Haemodialysis bicarbonate solution preparation mixer 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

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Haemodialysis bicarbonate solution preparation mixer

BiPro Bicarb Mixing/Distribution System by Medical Solutions International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haemodialysis bicarbonate solution preparation mixer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Medical Solutions International

Sources (1)

  • FDA UDI 7ab54a88-6f49-4042-a62a-90158fde7bb7 33 fields · synced May 30, 2026