INSTRUMENTATION LABORATORY COMPANY

Address:180 Hartwell Rd.,Bedford,MA,01730,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 ISE COOX TBILI (450 TEST) - 08426951027354 Catalog Number : 00055445009XC

Device Description : GEM 5000 BG ISE COOX TBILI 450 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca GEM 5000 BG ISE COOX TBILI 450 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 (600 TEST) - 08426951027361 Catalog Number : 00055360009XC

Device Description : GEM 5000 BG ISE COOX TBILI 600 Test PAK 21 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca+ GEM 5000 BG ISE COOX TBILI 600 Test PAK 21 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 GL COOX (75 TEST) - 08426951027378 Catalog Number : 00055407510XC

Device Description : GEM 5000 BG ISE GL COOX 75 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, GEM 5000 BG ISE GL COOX 75 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glu, Lac, 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 GL COOX (150 TEST) - 08426951027385 Catalog Number : 00055415010XC

Device Description : GEM 5000 BG ISE GL COOX 150 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, GEM 5000 BG ISE GL COOX 150 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glu, Lac, 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 GL COOX (300 TEST) - 08426951027392 Catalog Number : 00055430010XC

Device Description : GEM 5000 BG ISE GL COOX 300 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, GEM 5000 BG ISE GL COOX 300 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glu, Lac, 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 GL COOX (450 TEST) - 08426951027408 Catalog Number : 00055445010XC

Device Description : GEM 5000 BG ISE GL COOX 450 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, GEM 5000 BG ISE GL COOX 450 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glu, Lac, 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 GL COOX (600 TEST) - 08426951027415 Catalog Number : 00055360010XC

Device Description : GEM 5000 BG ISE GL COOX 600 Test PAK 21 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, GEM 5000 BG ISE GL COOX 600 Test PAK 21 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glu, Lac, 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 GL COOX TBILI (75 TEST) - 08426951027422 Catalog Number : 00055407511XC

Device Description : GEM 5000 BG ISE GL COOX TBILI 75 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, C GEM 5000 BG ISE GL COOX TBILI 75 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glu, Lac, 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 GL COOX TBILI (150 TEST) - 08426951027439 Catalog Number : 00055415011XC

Device Description : GEM 5000 BG ISE GL COOX TBILI 150 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, GEM 5000 BG ISE GL COOX TBILI 150 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glu, Lac, 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 GL COOX TBIL (300 TEST) - 08426951027446 Catalog Number : 00055430011XC

Device Description : GEM 5000 BG ISE GL COOX TBILI 300 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, GEM 5000 BG ISE GL COOX TBILI 300 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glu, Lac, 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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