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Vapotherm

FDA UDI

Class II (US FDA UDI)

by Vapotherm Inc.

Identity

Trade Name
Vapotherm FDA UDI
Generic Name
Professional high-flow respiratory unit, humidifying, manual FDA UDI
Device Name
Precision Flow Oxygen Assist Module, DPC LOW FDA UDI
Model / Reference
PF-OAMDPC-LOW FDA UDI
Description
Precision Flow Oxygen Assist Module, DPC LOW FDA UDI

Identifiers

Primary DI / UDI-DI
00841737103059 FDA UDI
FDA Product Code
QAV FDA UDI
BTT FDA UDI
GMDN Term
Professional high-flow respiratory unit, humidifying, manual 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

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Professional 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 2d5322b2-abc4-427d-8e33-e565a7c421a6 33 fields · synced Jun 1, 2026