INSTRUMENTATION LABORATORY COMPANY

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

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Filters

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 3000 iQM - BG HCT ELECT. - 450 Tests - 08426950082439 Catalog Number : 00024345087

Device Description : GEM Premier 3000 iQM 3WK - BG HCT ELECT. - 450 Tests

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

GEM Premier 3000 iQM - BG HCT ELECT. GL - 450 Tests - 08426950082446 Catalog Number : 00024345089

Device Description : GEM Premier 3000 iQM 3WK - BG HCT ELECT. GL - 450 Tests

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

GEM Premier 3000 iQM - BG HCT ELECT. - 600 Tests - 08426950082453 Catalog Number : 00024360087

Device Description : GEM Premier 3000 iQM 2WK - BG HCT ELECT. - 600 Tests

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

GEM Premier 3000 iQM - BG HCT ELECT. GL - 600 Tests - 08426950082460 Catalog Number : 00024360089

Device Description : GEM Premier 3000 iQM 2WK - BG HCT ELECT. GL - 600 Tests

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

GEM Premier 3000 - BG HCT - 150 Tests - 08426950082477 Catalog Number : 00024315004

Device Description : GEM Premier 3000 3WK - BG HCT - 150 Tests

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

GEM Premier 3000 - BG HCT ELECT. - 150 Tests - 08426950082484 Catalog Number : 00024315007

Device Description : GEM Premier 3000 3WK - BG HCT ELECT. - 150 Tests

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

GEM Premier 3000 - BG HCT ELECT. GL - 150 Tests - 08426950082491 Catalog Number : 00024315009

Device Description : GEM Premier 3000 3WK - BG HCT ELECT. GL - 150 Tests

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

GEM Premier 3000 - BG HCT - 300 Tests - 08426950082507 Catalog Number : 00024330004

Device Description : GEM Premier 3000 3WK - BG HCT - 300 Tests

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

GEM Premier 3000 - BG HCT ELECT. - 300 Tests - 08426950082514 Catalog Number : 00024330007

Device Description : GEM Premier 3000 3WK - BG HCT ELECT. - 300 Tests

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

GEM Premier 3000 - BG HCT ELECT GL - 300 Tests - 08426950082521 Catalog Number : 00024330009

Device Description : GEM Premier 3000 3WK - BG HCT ELECT GL - 300 Tests

Device Class : 2

Duns Number: 557223252

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

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