TNI medical AG

Address:Hofmannstrasse 8,Wuerzburg Bavaria,DE

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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

Humidifier, Respiratory Gas, (Direct Patient Interface) (BTT) (10)

Premarket Exempt

Clear

softFlow - 04059163000040 Catalog Number : 40630001

Device Description : Applicator Clinic Small softFlow 50

Device Class : 2

Duns Number: 312602830

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

softFlow - 04059163000057 Catalog Number : 40630002

Device Description : Applicator Clinic Standard softFlow 50

Device Class : 2

Duns Number: 312602830

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

softFlow - 04059163000064 Catalog Number : 40630005

Device Description : Applicator Clinic Std.-Plus softFlow 50

Device Class : 2

Duns Number: 312602830

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

softFlow - 04059163000071 Catalog Number : 40630013

Device Description : Applicator Clinic Large softFlow 50

Device Class : 2

Duns Number: 312602830

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

softFlow - 04059163000224 Catalog Number : 40641107

Device Description : Humidifier Rack Clinic softFlow

Device Class : 2

Duns Number: 312602830

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

softFlow - 04059163000231 Catalog Number : 40641108

Device Description : Air Bridge Humidifier softFlow

Device Class : 2

Duns Number: 312602830

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

softFlow - 04059163000408 Catalog Number : 40620061

Device Description : Protective Cap f. Oxygen Inlet White, softFlow, 5 Pieces

Device Class : 2

Duns Number: 312602830

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

softFlow - 04059163000415 Catalog Number : 40610021

Device Description : TNI softFlow 50

Device Class : 2

Duns Number: 312602830

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

softFlow - 04059163000545 Catalog Number : 40620040

Device Description : Humidifier Clinic Hygiene Set softFlow

Device Class : 2

Duns Number: 312602830

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

softFlow - 04059163000620 Catalog Number : 40620600

Device Description : Accessories Set Clinic USA softFlow 50

Device Class : 2

Duns Number: 312602830

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

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