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softFlow

FDA UDI

Class II (US FDA UDI)

by Tni Medical AG

Identity

Trade Name
softFlow FDA UDI
Generic Name
Professional high-flow respiratory unit, humidifying, manual FDA UDI
Device Name
Protective Cap f. Oxygen Inlet White, softFlow, 5 Pieces FDA UDI
Model / Reference
40620061 FDA UDI
Description
Protective Cap f. Oxygen Inlet White, softFlow, 5 Pieces FDA UDI

Identifiers

Catalog Number
40620061 FDA UDI
Primary DI / UDI-DI
04059163000408 FDA UDI
FDA Product Code
BTT FDA UDI
GMDN Term
Professional high-flow respiratory unit, humidifying, manual FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Professional high-flow respiratory unit, humidifying, manual

softFlow by Tni Medical AG — 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
Tni Medical AG

Sources (1)

  • FDA UDI 01287fc8-7215-4197-ac50-7e2c3f4c94b1 36 fields · synced May 30, 2026