VAPOTHERM, INC.

Address:100 Domain Dr,Exeter,NH,03833,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

Humidifier, Respiratory Gas, (Direct Patient Interface) (BTT) (1)

Premarket Exempt

No Yes

Clear

Vapotherm - 00841737102038 Catalog Number :

Device Description : HVT 2.0 Patient Air Filter

Device Class : 2

Duns Number: 040429050

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

vapotherm - 00841737102052 Catalog Number :

Device Description : Precision Flow Annual PM Kit

Device Class :

Duns Number: 040429050

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Vapotherm - 00841737102069 Catalog Number :

Device Description : Precision Flow Bi-Annual PM Kit

Device Class :

Duns Number: 040429050

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Vapotherm - 00841737102076 Catalog Number :

Device Description : Precision Flow Plus Startup Kit United States

Device Class :

Duns Number: 040429050

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Vapotherm - 00841737102083 Catalog Number :

Device Description : Precision Flow Startup Kit, Israel

Device Class :

Duns Number: 040429050

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Vapotherm - 00841737102090 Catalog Number :

Device Description : Precision Flow Heliox Startup Kit, Turkey

Device Class :

Duns Number: 040429050

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Vapotherm - 00841737102106 Catalog Number :

Device Description : Precision Flow Plus UKIT Great Britain

Device Class :

Duns Number: 040429050

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Vapotherm - 00841737102113 Catalog Number :

Device Description : Precision Flow Plus UKIT France

Device Class :

Duns Number: 040429050

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Vapotherm - 00841737102120 Catalog Number :

Device Description : Precision Flow Plus UKIT Germany

Device Class :

Duns Number: 040429050

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Vapotherm - 00841737102137 Catalog Number :

Device Description : Precision Flow Vapotherm Transfer Unit, NIST

Device Class :

Duns Number: 040429050

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

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