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WaterCheckRC

FDA UDI

Class II (US FDA UDI)

by IBT Scientific

Identity

Trade Name
WaterCheckRC FDA UDI
Generic Name
Haemodialysis equipment residual chlorine test strip FDA UDI
Device Name
1 bottle has 100 test strips for testing residual chlorine in rinse water FDA UDI
Model / Reference
RC22101 FDA UDI
Description
1 bottle has 100 test strips for testing residual chlorine in rinse water FDA UDI

Identifiers

Primary DI / UDI-DI
G212RC22101 FDA UDI
510(k) Number
K953854 FDA UDI
FDA Product Code
FKP FDA UDI
GMDN Term
Haemodialysis equipment residual chlorine test strip 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

No

FDA UDI

Over-the-Counter

Yes

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 equipment residual chlorine test strip

WaterCheckRC by IBT Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haemodialysis equipment residual chlorine test strip.

Cleared under the same submission

K953854 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
IBT Scientific

Sources (1)

  • FDA UDI 42834c87-0a7a-43d8-834d-60df78b7a808 35 fields · synced May 30, 2026