← Back to catalogue

Gem Opl (220v)

FDA UDI

Class I (US FDA UDI)

by Instrumentation Laboratory Company

Identity

Trade Name
GEM OPL (220V) FDA UDI
Generic Name
Blood gas/haemoximetry analyser IVD, laboratory FDA UDI
Device Name
GEM OPL (220V) FDA UDI
Model / Reference
06320480001 FDA UDI
Description
GEM OPL (220V) FDA UDI

Identifiers

Catalog Number
06320480001 FDA UDI
Primary DI / UDI-DI
08426950490791 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
Not 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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Gem Opl (220v) by Instrumentation Laboratory Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K951485 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Instrumentation Laboratory Company

Sources (1)

  • FDA UDI f124169f-39ab-4484-99b3-ba6aa6be4755 38 fields · synced May 30, 2026