VENNI INSTRUMENTS INC.

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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

Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms) (MWI) (4) Electrocardiograph (DPS) (3) Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (MHX) (3)

Premarket Exempt

Clear

Biolight - 00852503007105 Catalog Number :

Device Description : Biolight 12.1" multi-parameter patient monitor

Device Class : 2

Duns Number: 960516735

Premarket Exempt : No

Product Code : MHX

Prescription Use : No

Device Count : 1

Biolight - 00852503007112 Catalog Number :

Device Description : Biolight 15.1" multi-parameter patient monitor

Device Class : 2

Duns Number: 960516735

Premarket Exempt : No

Product Code : MHX

Prescription Use : No

Device Count : 1

Biolight - 00852503007129 Catalog Number :

Device Description : Biolight 12.1" multi-parameter modular patient monitor

Device Class : 2

Duns Number: 960516735

Premarket Exempt : No

Product Code : MWI

Prescription Use : No

Device Count : 1

Biolight - 00852503007136 Catalog Number :

Device Description : Biolight 15.1" multi-parameter modular patient monitor

Device Class : 2

Duns Number: 960516735

Premarket Exempt : No

Product Code : MWI

Prescription Use : No

Device Count : 1

Biolight - 00852503007143 Catalog Number :

Device Description : Biolight 7" multi-parameter patient monitor

Device Class : 2

Duns Number: 960516735

Premarket Exempt : No

Product Code : MHX

Prescription Use : No

Device Count : 1

Biolight - 00852503007150 Catalog Number :

Device Description : Biolight Vital Signs Monitor

Device Class : 2

Duns Number: 960516735

Premarket Exempt : No

Product Code : MWI

Prescription Use : No

Device Count : 1

Venni / Biolight - 00852503007167 Catalog Number :

Device Description : Venni / Biolight 12.1" multi-parameter modular patient monitor

Device Class : 2

Duns Number: 960516735

Premarket Exempt : No

Product Code : MWI

Prescription Use : No

Device Count : 1

Venni / Biolight - 00852503007174 Catalog Number :

Device Description : Venni / Biolight 3-channel EKG machine

Device Class : 2

Duns Number: 960516735

Premarket Exempt : No

Product Code : DPS

Prescription Use : No

Device Count : 1

Venni / Biolight - 00852503007181 Catalog Number :

Device Description : Venni / Biolight 12-channel EKG machine

Device Class : 2

Duns Number: 960516735

Premarket Exempt : No

Product Code : DPS

Prescription Use : No

Device Count : 1

Venni / Biolight - 00852503007198 Catalog Number :

Device Description : Venni / Biolight 12-channel EKG machine

Device Class : 2

Duns Number: 960516735

Premarket Exempt : No

Product Code : DPS

Prescription Use : No

Device Count : 1

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