MONICA HEALTHCARE LIMITED

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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

Uterine Electromyographic Monitor (OSP) (8) Electrode, Electrocardiograph (DRX) (1)

Premarket Exempt

Clear

Novii - 05060433670015 Catalog Number :

Device Description : Novii Wireless Patch System (GEHC)

Device Class : 2

Duns Number: 346332666

Premarket Exempt : No

Product Code : OSP

Prescription Use : No

Device Count : 1

Novii - 05060433670053 Catalog Number :

Device Description : Novii Interface

Device Class : 2

Duns Number: 346332666

Premarket Exempt : No

Product Code : OSP

Prescription Use : Yes

Device Count : 1

Novii - 05060433670060 Catalog Number :

Device Description : Novii Pod

Device Class :

Duns Number: 346332666

Premarket Exempt : No

Product Code : OSP

Prescription Use : Yes

Device Count : 1

Monica - 05060433670091 Catalog Number :

Device Description : Monica Interface CTG Cable - GE Corometrics FECG round black connector

Device Class : 2

Duns Number: 346332666

Premarket Exempt : No

Product Code : OSP

Prescription Use : Yes

Device Count : 1

Monica - 05060433670107 Catalog Number :

Device Description : Monica Interface CTG Cable - GE Corometrics FECG green rectangular connector

Device Class : 2

Duns Number: 346332666

Premarket Exempt : No

Product Code : OSP

Prescription Use : Yes

Device Count : 1

Monica - 05060433670114 Catalog Number :

Device Description : Monica Interface CTG Cable - GE Corometrics MECG round green connector

Device Class : 2

Duns Number: 346332666

Premarket Exempt : No

Product Code : OSP

Prescription Use : Yes

Device Count : 1

Monica - 05060433670138 Catalog Number :

Device Description : Monica Interface CTG Cable - GE Corometrics UA round white connector

Device Class : 2

Duns Number: 346332666

Premarket Exempt : No

Product Code : OSP

Prescription Use : Yes

Device Count : 1

Novii - 05060433670244 Catalog Number :

Device Description : Novii Interface Power Supply

Device Class : 2

Duns Number: 346332666

Premarket Exempt : No

Product Code : OSP

Prescription Use : Yes

Device Count : 1

Novii - 15060433670074 Catalog Number :

Device Description : Novii Patch

Device Class : 2

Duns Number: 346332666

Premarket Exempt : No

Product Code : DRX

Prescription Use : No

Device Count : 1

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