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) (9) High Flow/High Velocity Humidified Oxygen Delivery Device (QAV) (3)

Premarket Exempt

No Yes

Clear

Vapotherm - 00841737105459 Catalog Number :

Device Description : Oxygen Assist Module Nellcor, UKIT Philippines Version

Device Class : 2

Duns Number: 040429050

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

Vapotherm - 00841737105466 Catalog Number :

Device Description : HVT 2.0 UKIT, GB Version

Device Class : 2

Duns Number: 040429050

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

Vapotherm - 00841737105473 Catalog Number :

Device Description : HVT 2.0 UKIT, NIST Version

Device Class : 2

Duns Number: 040429050

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

Vapotherm - 00841737105480 Catalog Number :

Device Description : VTU NIST Manifold Kit

Device Class : 2

Duns Number: 040429050

Premarket Exempt : No

Product Code : QAV, BTT

Prescription Use : No

Device Count : 1

Vapotherm - 00841737105497 Catalog Number :

Device Description : Medipower Battery Module

Device Class : 2

Duns Number: 040429050

Premarket Exempt : No

Product Code : QAV, BTT

Prescription Use : No

Device Count : 1

Vapotherm - 00841737105503 Catalog Number :

Device Description : Medipower Power Supply

Device Class : 2

Duns Number: 040429050

Premarket Exempt : No

Product Code : QAV, BTT

Prescription Use : No

Device Count : 1

Vapotherm - 00841737105510 Catalog Number :

Device Description : HVT-UKIT-DISS-EU

Device Class : 2

Duns Number: 040429050

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

Vapotherm - 00841737105534 Catalog Number :

Device Description : HVT UKIT, Argentina Version

Device Class : 2

Duns Number: 040429050

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

Vapotherm - 00841737105541 Catalog Number :

Device Description : HVT UKIT, Australia Version

Device Class : 2

Duns Number: 040429050

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

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