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Serim® GUARDIAN™ Blood Leak Test Strips

FDA UDI

Class II (US FDA UDI)

by Serim Research Corp.

Identity

Trade Name
Serim® GUARDIAN™ Blood Leak Test Strips FDA UDI
Generic Name
Haemodialysis system blood leak detector FDA UDI
Device Name
Serim® GUARDIAN™ Blood Leak Test Strips provide a rapid method to test dialysate for blood if a dialyzer membrane leak is suspected during the hemodialysis procedure. FDA UDI
Model / Reference
5119C FDA UDI
Description
Serim® GUARDIAN™ Blood Leak Test Strips provide a rapid method to test dialysate for blood if a dialyzer membrane leak is suspected during the hemodialysis procedure. FDA UDI

Identifiers

Catalog Number
5119C FDA UDI
Primary DI / UDI-DI
M1745119C FDA UDI
510(k) Number
K012115 FDA UDI
FDA Product Code
FJD FDA UDI
GMDN Term
Haemodialysis system blood leak detector 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Haemodialysis system blood leak detector

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

Similar devices

Also classified as Haemodialysis system blood leak detector.

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 e7eed404-9689-42d2-8b91-682f75550c0d 37 fields · synced Jun 6, 2026