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Gem Opl Cuvettes

FDA UDI

Class I (US FDA UDI)

by Instrumentation Laboratory Company

Identity

Trade Name
GEM OPL CUVETTES FDA UDI
Generic Name
Blood gas/haemoximetry analyser IVD, laboratory FDA UDI
Device Name
GEM OPL CUVETTES FDA UDI
Model / Reference
06320480100 FDA UDI
Description
GEM OPL CUVETTES FDA UDI

Identifiers

Catalog Number
06320480100 FDA UDI
Primary DI / UDI-DI
08426950088684 FDA UDI
510(k) Number
K951485 FDA UDI
FDA Product Code
JKS FDA UDI
GMDN Term
Blood gas/haemoximetry analyser IVD, laboratory FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.3220 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: Blood gas/haemoximetry analyser IVD, laboratory

Gem Opl Cuvettes by Instrumentation Laboratory Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blood gas/haemoximetry analyser IVD, laboratory.

Cleared under the same submission

K951485 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Instrumentation Laboratory Company

Sources (1)

  • FDA UDI 3e850c25-7459-4aaf-b7d0-d3eb411b1aac 37 fields · synced Jun 8, 2026