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EZ-Chek

FDA UDI

Class II (US FDA UDI)

by Reprocessing Products Corp

Identity

Trade Name
EZ-Chek FDA UDI
Generic Name
Haemodialysis treatment kit FDA UDI
Device Name
Residual Chlorine Test Strip K100-0101B FDA UDI
Model / Reference
5100A FDA UDI
Description
Residual Chlorine Test Strip K100-0101B FDA UDI

Identifiers

Catalog Number
K100-0101B FDA UDI
Primary DI / UDI-DI
00858293006380 FDA UDI
510(k) Number
K901734 FDA UDI
FDA Product Code
MSY FDA UDI
GMDN Term
Haemodialysis treatment kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5665 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 treatment kit

EZ-Chek by Reprocessing Products Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Haemodialysis treatment kit.

Cleared under the same submission

K901734 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Reprocessing Products Corp

Sources (1)

  • FDA UDI 99e97397-7d22-4776-a76e-95facb74034d 35 fields · synced May 30, 2026