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Vapotherm

FDA UDI

Class II (US FDA UDI)

by Vapotherm Inc.

Identity

Trade Name
Vapotherm FDA UDI
Generic Name
Electrical mains power cable FDA UDI
Device Name
HVT 2.0 OAM-capable capital unit, Nellcor compatibility FDA UDI
Model / Reference
HVT20-NEL FDA UDI
Description
HVT 2.0 OAM-capable capital unit, Nellcor compatibility FDA UDI

Identifiers

Primary DI / UDI-DI
00841737103950 FDA UDI
FDA Product Code
QAV FDA UDI
BTT FDA UDI
GMDN Term
Electrical mains power cable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5454 FDA UDI
868.5450 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Respiratory oxygen sensorElectrical mains power cableProfessional high-flow respiratory unit, humidifying, manual

Vapotherm by Vapotherm Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Professional high-flow respiratory unit, humidifying, manual.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vapotherm Inc.

Sources (1)

  • FDA UDI ad2b5e99-c359-46ce-a11f-b795515bd55f 33 fields · synced Jun 1, 2026