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GEM Premier 5000 PAK BG/COOX 600 TEST

FDA UDI

Class II (US FDA UDI)

by Instrumentation Laboratory Company

Identity

Trade Name
GEM Premier 5000 PAK BG/COOX 600 TEST FDA UDI
Generic Name
Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies FDA UDI
Device Name
GEM Premier 5000 PAK pH, pCO2, pO2, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 600 Test 21 Days FDA UDI
Model / Reference
00055360004 FDA UDI
Description
GEM Premier 5000 PAK pH, pCO2, pO2, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 600 Test 21 Days FDA UDI

Identifiers

Catalog Number
00055360004 FDA UDI
Primary DI / UDI-DI
08426950899662 FDA UDI
FDA Product Code
CHL FDA UDI
GHS FDA UDI
GLY FDA UDI
GMDN Term
Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1120 FDA UDI
864.7425 FDA UDI
864.7500 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies

GEM Premier 5000 PAK BG/COOX 600 TEST by Instrumentation Laboratory Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies.

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 600bf2d3-3da4-4708-8670-7c0ca97ee708 36 fields · synced May 30, 2026