NOVA BIOMEDICAL CORPORATION

Address:200 Prospect St,WALTHAM,MA,02454,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

Clear

Stat Profile - 00385480616140 Catalog Number : 61614

Device Description : Stat Profile Prime Plus MicroSensor Card™ with COOX (High Volume)

Device Class : 2

Duns Number: 070617139

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

Stat Profile - 00385480616157 Catalog Number : 61615

Device Description : Stat Profile Prime Plus MicroSensor Card™ with COOX

Device Class : 2

Duns Number: 070617139

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

Stat Profile - 00385480622257 Catalog Number : 62225

Device Description : Prime Calibrator Cartridge ES Plus 100 Sample

Device Class : 2

Duns Number: 070617139

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

Stat Profile - 00385480622264 Catalog Number : 62226

Device Description : Prime Calibrator Cartridge ES Plus 200 Sample

Device Class : 2

Duns Number: 070617139

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

Stat Profile - 00385480622271 Catalog Number : 62227

Device Description : Prime Calibrator Cartridge ES Plus 300 Sample

Device Class : 2

Duns Number: 070617139

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

Stat Profile - 00385480622288 Catalog Number : 62228

Device Description : Prime Calibrator Cartridge ES Plus 400 Sample

Device Class : 2

Duns Number: 070617139

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

Stat Profile - 00385480622295 Catalog Number : 62229

Device Description : Prime Calibrator Cartridge ES Plus 500 Sample

Device Class : 2

Duns Number: 070617139

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

Stat Profile - 00385480622301 Catalog Number : 62230

Device Description : Prime Calibrator Cartridge ES Plus 600 Sample

Device Class : 2

Duns Number: 070617139

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

Stat Profile - 00385480623384 Catalog Number : 62338

Device Description : Prime ES Plus

Device Class : 2

Duns Number: 070617139

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

Stat Profile - 00385480623414 Catalog Number : 62341

Device Description : Prime ES Plus W/ Scanner

Device Class : 2

Duns Number: 070617139

Premarket Exempt : No

Product Code : CHL

Prescription Use : Yes

Device Count : 1

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