imtmedical ag

Address:GEWERBESTRASSE 8,BUCHS Sankt Gallen,CH

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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

SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS) (BZO) (3) Compressor, Air, Portable (BTI) (2) Ventilator, Continuous, Facility Use (CBK) (1)

Premarket Exempt

No Yes

Clear

EVair - 07640149381023 Catalog Number :

Device Description : The medical air compressor is intended for use as an integrated, optional access The medical air compressor is intended for use as an integrated, optional accessory to provide a dry, filtered, breathable compressed air supply to GE Datex-Ohmeda Engström Carestation and Engström Pro ventilators.

Device Class :

Duns Number: 483243700

Premarket Exempt : Yes

Product Code : BTI

Prescription Use : Yes

Device Count : 1

EVair - 07640149381030 Catalog Number :

Device Class :

Duns Number: 483243700

Premarket Exempt : Yes

Product Code : BTI

Prescription Use : Yes

Device Count : 1

bellavista - 07640149381115 Catalog Number :

Device Description : The bellavista ventilator is intended to provide positive pressure ventilator su The bellavista ventilator is intended to provide positive pressure ventilator support to adults and pediatrics (IBW greater than 6 kg). Environment of use: Hospitals, sub-acute care facilities and intra-hospital transfer. It is inteded for use by qualified, trained personnel under the directionof a physician.

Device Class : 2

Duns Number: 483243700

Premarket Exempt : No

Product Code : CBK

Prescription Use : Yes

Device Count : 1

imtmedical - 07640149381344 Catalog Number : 301.328.010

Device Description : iFlow 200 S Adult/Pediatric Proximal Flow Sensor

Device Class : 1

Duns Number: 483243700

Premarket Exempt : Yes

Product Code : BZO

Prescription Use : Yes

Device Count : 1

imtmedical - 07640149381351 Catalog Number : 301.470.010

Device Description : iFlow 40 S Neonatal/Infant Proximal Flow Sensor

Device Class : 1

Duns Number: 483243700

Premarket Exempt : Yes

Product Code : BZO

Prescription Use : Yes

Device Count : 1

imtmedical - 07640149383836 Catalog Number : 302.578.000

Device Description : iFlow 40 SC Neonatal/Infant Proximal Flow Sensor

Device Class : 1

Duns Number: 483243700

Premarket Exempt : Yes

Product Code : BZO

Prescription Use : Yes

Device Count : 1

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