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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
0 -14 pH Test Strips FDA UDI
Model / Reference
K100-0104 FDA UDI
Description
0 -14 pH Test Strips FDA UDI

Identifiers

Catalog Number
K100-0104 FDA UDI
Primary DI / UDI-DI
00858293006151 FDA UDI
510(k) Number
K101750 FDA UDI
FDA Product Code
MNV FDA UDI
GMDN Term
Haemodialysis treatment kit 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 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

K101750 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 3bea7e90-ecbc-4066-af8b-f0b40436152e 35 fields · synced May 30, 2026