INSTRUMENTATION LABORATORY COMPANY

Address:526 Route 303,ORANGEBURG,NY,10962,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH (CHL) (10)

Premarket Exempt

No Yes

Clear

GEM Premier 5000 PAK BG COOX TBILI (450 TEST) - 08426951027255 Catalog Number : 00055445005XC

Device Description : GEM 5000 BG COOX TBILI 450 Test PAK 31 DAY (pH, pCO2, pO2, Hct, tHb, O2Hb, COHb GEM 5000 BG COOX TBILI 450 Test PAK 31 DAY (pH, pCO2, pO2, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2, tBili Cartridge)

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

GEM Premier 5000 PAK BG COOX TBILI (600 TEST) - 08426951027262 Catalog Number : 00055360005XC

Device Description : GEM 5000 BG COOX TBILI 600 Test PAK 21 DAY (pH, pCO2, pO2, Hct, tHb, O2Hb, COHb GEM 5000 BG COOX TBILI 600 Test PAK 21 DAY (pH, pCO2, pO2, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2, tBili Cartridge)

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

GEM Premier 5000 PAK BG ISE COOX (75 TEST) - 08426951027279 Catalog Number : 00055407508XC

Device Description : GEM 5000 BG ISE COOX 75 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct GEM 5000 BG ISE COOX 75 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge)

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

GEM Premier 5000 PAK BG ISE COOX (150 TEST) - 08426951027286 Catalog Number : 00055415008XC

Device Description : GEM 5000 BG ISE COOX 150 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct GEM 5000 BG ISE COOX 150 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge)

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

GEM Premier 5000 PAK BG ISE COOX (300 TEST) - 08426951027293 Catalog Number : 00055430008XC

Device Description : GEM 5000 BG ISE COOX 300 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct GEM 5000 BG ISE COOX 300 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge)

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

GEM Premier 5000 PAK BG ISE COOX (450 TEST) - 08426951027309 Catalog Number : 00055445008XC

Device Description : GEM 5000 BG ISE COOX 450 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct GEM 5000 BG ISE COOX 450 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge)

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

GEM Premier 5000 PAK BG ISE COOX (600 TEST) - 08426951027316 Catalog Number : 00055360008XC

Device Description : GEM 5000 BG ISE COOX 600 Test PAK 21 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct GEM 5000 BG ISE COOX 600 Test PAK 21 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge)

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

GEM Premier 5000 PAK BG ISE COOX TBILI (75 TEST) - 08426951027323 Catalog Number : 00055407509XC

Device Description : GEM 5000 BG ISE COOX TBILI 75 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++ GEM 5000 BG ISE COOX TBILI 75 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2, Tbili Cartridge)

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

GEM Premier 5000 PAK BG ISE COOX TBILI (150 TEST) - 08426951027330 Catalog Number : 00055415009XC

Device Description : GEM 5000 BG ISE COOX TBILI 150 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca GEM 5000 BG ISE COOX TBILI 150 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2, Tbili Cartridge)

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

GEM Premier 5000 PAK BG ISE COOX TBILI (300 TEST) - 08426951027347 Catalog Number : 00055430009XC

Device Description : GEM 5000 BG ISE COOX TBILI 300 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca+ GEM 5000 BG ISE COOX TBILI 300 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2, Tbili Cartridge)

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

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