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GEM Premier 7000 with iQM3 PAK (BG +3 more)

FDA UDI

Class II (US FDA UDI)

by Instrumentation Laboratory Company

Identity

Trade Name
GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 300 Tests) FDA UDI
Generic Name
Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies FDA UDI
Device Name
GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (300 Tests, 31 days) FDA UDI
Model / Reference
00077430010 FDA UDI
Description
GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (300 Tests, 31 days) FDA UDI

Identifiers

Primary DI / UDI-DI
00195226000641 FDA UDI
510(k) Number
K223608 FDA UDI
FDA Product Code
CHL FDA UDI
GMDN Term
Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies FDA UDI
Models / Variants
BG FDA UDI
ISE FDA UDI
GL FDA UDI
COOX 300 Tests 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

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 7000 with iQM3 PAK (BG +3 more) by Instrumentation Laboratory Company — Class II — FDA UDI — listed in FDA GUDID — 4 models

Similar devices

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

Cleared under the same submission

K223608 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 429af3fc-978c-4bf4-986d-cbe0e883f141 36 fields · synced Jun 1, 2026