DATEX-OHMEDA INC

Address:9900 Innovation Drive,Wauwatosa,WI,53226,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

ABSORBER, CARBON-DIOXIDE (BSF) (2) Uterine electromyographic monitor (OSP) (2) VAPORIZER, ANESTHESIA, NON-HEATED (CAD) (1) WARMER, INFANT RADIANT (FMT) (1)

Premarket Exempt

No Yes

Clear

TEC - 00840682124751 Catalog Number :

Device Description : TEC 850 ISO

Device Class : 2

Duns Number: 129501685

Premarket Exempt : No

Product Code : CAD

Prescription Use : No

Device Count : 1

NA - 00840682134880 Catalog Number :

Device Class : 1

Duns Number: 129501685

Premarket Exempt : Yes

Product Code : BSF

Prescription Use : Yes

Device Count : 1

NA - 00840682135290 Catalog Number :

Device Class : 1

Duns Number: 129501685

Premarket Exempt : Yes

Product Code : BSF

Prescription Use : Yes

Device Count : 1

Novii - 00840682142700 Catalog Number :

Device Description : DRU_NOVII INTERFACE- INTERNATIONAL

Device Class : 2

Duns Number: 080887689

Premarket Exempt : No

Product Code : OSP

Prescription Use : Yes

Device Count : 1

Novii - 00840682142731 Catalog Number :

Device Description : DRU_NOVII POD

Device Class : 2

Duns Number: 080887689

Premarket Exempt : No

Product Code : OSP

Prescription Use : Yes

Device Count : 1

Panda - 00840682152709 Catalog Number :

Device Class : 2

Duns Number: 080887689

Premarket Exempt : No

Product Code : FMT

Prescription Use : Yes

Device Count : 1

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