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GEM Premier 5000 PAK BG/ISE/COOX/TBILI 450 TEST

FDA UDI

Class II (US FDA UDI)

by Instrumentation Laboratory Company

Identity

Trade Name
GEM Premier 5000 PAK BG/ISE/COOX/TBILI 450 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, Na+, K+, Cl-, Ca++, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 450 Test 31 Days FDA UDI
Model / Reference
00055445009 FDA UDI
Description
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 450 Test 31 Days FDA UDI

Identifiers

Catalog Number
00055445009 FDA UDI
Primary DI / UDI-DI
08426950807803 FDA UDI
510(k) Number
K160225 FDA UDI
K160402 FDA UDI
K160415 FDA UDI
K173403 FDA UDI
K203790 FDA UDI
FDA Product Code
CHL FDA UDI
GHS FDA UDI
JFP FDA UDI
JGS FDA UDI
MQM FDA UDI
GLY FDA UDI
CEM FDA UDI
CGZ 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
862.1145 FDA UDI
862.1665 FDA UDI
862.1113 FDA UDI
864.7500 FDA UDI
862.1600 FDA UDI
862.1170 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/ISE/COOX/TBILI 450 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.

Cleared under the same submission

K160225 also covers:

K160402 also covers:

K160415 also covers:

K173403 also covers:

K203790 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 e4be3a3a-f2ad-4f87-bfc9-1ce8ef7e07eb 37 fields · synced May 30, 2026