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Synermed®

FDA UDI

Class II (US FDA UDI)

by Infrared Laboratory Systems Llc

Identity

Trade Name
Synermed® FDA UDI
Generic Name
Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent FDA UDI
Device Name
Hitachi ISE Internal Reference 6 X 1000 mL FDA UDI
Model / Reference
ISE710 FDA UDI
Description
Hitachi ISE Internal Reference 6 X 1000 mL FDA UDI

Identifiers

Catalog Number
ISE710 FDA UDI
Primary DI / UDI-DI
05060500091040 FDA UDI
510(k) Number
K952179 FDA UDI
FDA Product Code
JGS FDA UDI
CGZ FDA UDI
CEM FDA UDI
GMDN Term
Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1665 FDA UDI
862.1170 FDA UDI
862.1600 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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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: Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent

Synermed® by Infrared Laboratory Systems Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent.

Cleared under the same submission

K952179 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Infrared Laboratory Systems Llc

Sources (1)

  • FDA UDI b5704a7c-4a4f-40d6-a9ab-7a271c327963 37 fields · synced May 30, 2026