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GEM Premier 3000

FDA UDI

Class II (US FDA UDI)

by Instrumentation Laboratory Company

Identity

Trade Name
GEM Premier 3000 FDA UDI
Generic Name
Blood gas/haemoximetry analyser IVD, laboratory FDA UDI
Device Name
GEM Premier 3000 FDA UDI
Model / Reference
00057000100 FDA UDI
Description
GEM Premier 3000 FDA UDI

Identifiers

Catalog Number
00057000100 FDA UDI
Primary DI / UDI-DI
08426950452553 FDA UDI
510(k) Number
K161818 FDA UDI
K992834 FDA UDI
FDA Product Code
CHL FDA UDI
GMDN Term
Blood gas/haemoximetry analyser IVD, laboratory FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1120 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

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

Category: Blood gas/haemoximetry analyser IVD, laboratory

GEM Premier 3000 by Instrumentation Laboratory Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

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 cc556a1c-0139-4ef0-b27f-deb732d88e70 37 fields · synced Jun 1, 2026