EnviteC-Wismar GmbH

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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

Oximeter (DQA) (8) Transducer, Gas Flow (BXP) (1) Transducer, Gas Pressure, Differential (BYR) (1)

Premarket Exempt

No Yes

Clear

Flow sensor - 04036616001809 Catalog Number : 1000470

Device Description : Flow sensor SpiroQuant A+

Device Class : 1

Duns Number: 330943838

Premarket Exempt : Yes

Product Code : BXP

Prescription Use : Yes

Device Count : 1

Flow sensor - 04036616001816 Catalog Number : 07-00-0001

Device Description : Flow sensor SpiroQuant H

Device Class : 1

Duns Number: 330943838

Premarket Exempt : Yes

Product Code : BYR

Prescription Use : Yes

Device Count : 1

SoftTip® large - 04036616001830 Catalog Number : 06-00-0115

Device Description : SoftTip® large R-2182-3 Minolta

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

SoftTip® large - 04036616001854 Catalog Number : 06-00-1070

Device Description : SoftTip® large R-2203-16 Nihon Kohden

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

SoftTip large - 04036616001861 Catalog Number : 06-00-0725

Device Description : SoftTip large R-2412 HP/Philips

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

SoftTip large - 04036616001885 Catalog Number : 06-00-0723

Device Description : SoftTip large R-2414-15 HP/Philips

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

SoftTip large - 04036616001908 Catalog Number : 06-00-0711

Device Description : SoftTip large R-3212-9 Nellcor

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

SoftTip large - 04036616001939 Catalog Number : 06-00-0709

Device Description : SoftTip large R-3212-31 Nellcor

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

SoftTip large - 04036616001946 Catalog Number : 06-00-0584

Device Description : SoftTip large R-3222-12 BCI

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

SoftTip large - 04036616002028 Catalog Number : 06-00-0715

Device Description : SoftTip large R-3412 Ohmeda

Device Class : 2

Duns Number: 330943838

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

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