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) (10) High Flow/High Velocity Humidified Oxygen Delivery Device (QAV) (1)

Premarket Exempt

No Yes

Clear

Vapotherm - 00841737105237 Catalog Number :

Device Description : ProSoft Pediatric Adult Small, Philippines Version

Device Class : 2

Duns Number: 040429050

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

Vapotherm - 00841737105244 Catalog Number :

Device Description : ProSoft Pediatric Small, Philippines Version

Device Class : 2

Duns Number: 040429050

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

Vapotherm - 00841737105251 Catalog Number :

Device Description : ProSoft Premature, Philippines Version

Device Class : 2

Duns Number: 040429050

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

Vapotherm - 00841737105268 Catalog Number :

Device Description : ProSoft X-Large, Philippines Version

Device Class : 2

Duns Number: 040429050

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

Vapotherm - 00841737105275 Catalog Number :

Device Description : SOLO1300, Philippines Version

Device Class : 2

Duns Number: 040429050

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

Vapotherm - 00841737105299 Catalog Number :

Device Description : ProSoft Adult, Philippines Version

Device Class : 2

Duns Number: 040429050

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

Vapotherm - 00841737105305 Catalog Number :

Device Description : HVT 2.0 Battery

Device Class : 2

Duns Number: 040429050

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

Vapotherm - 00841737105312 Catalog Number :

Device Description : Oxygen Assist Module Masimo, UKIT India Version

Device Class : 2

Duns Number: 040429050

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

Vapotherm - 00841737105329 Catalog Number :

Device Description : Oxygen Assist Module Nellcor, UKIT India Version

Device Class : 2

Duns Number: 040429050

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

Vapotherm - 00841737105336 Catalog Number :

Device Description : HVT 2.0 VTU NIST

Device Class : 2

Duns Number: 040429050

Premarket Exempt : No

Product Code : QAV, BTT

Prescription Use : No

Device Count : 1

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