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Serim® GUARDIAN™ Residual Formaldehyde Test Strips

FDA UDI

Class II (US FDA UDI)

by Serim Research Corp.

Identity

Trade Name
Serim® GUARDIAN™ Residual Formaldehyde Test Strips FDA UDI
Generic Name
Multi-parameter device tester FDA UDI
Device Name
Serim® GUARDIAN™ Residual Formaldehyde Test Strips measure the concentration of formaldehyde remaining after rinsing dialyzers or dialysate lines prior to use in hemodialysis. FDA UDI
Model / Reference
5112 FDA UDI
Description
Serim® GUARDIAN™ Residual Formaldehyde Test Strips measure the concentration of formaldehyde remaining after rinsing dialyzers or dialysate lines prior to use in hemodialysis. FDA UDI

Identifiers

Catalog Number
5112 FDA UDI
Primary DI / UDI-DI
M17451121 FDA UDI
510(k) Number
K914123 FDA UDI
FDA Product Code
LIF FDA UDI
GMDN Term
Multi-parameter device tester 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

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: Multi-parameter device tester

Serim® GUARDIAN™ Residual Formaldehyde Test Strips by Serim Research Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multi-parameter device tester.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Serim Research Corp.

Sources (1)

  • FDA UDI 0498db39-1802-49e3-a0c9-7db0e58b5f61 37 fields · synced May 30, 2026