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Provox® FreeHands HME® Flow

FDA UDI

Class II (US FDA UDI)

by Atos Medical Inc.

Identity

Trade Name
Provox® FreeHands HME® Flow FDA UDI
Generic Name
Tracheostomy tube speech valve FDA UDI
Device Name
Provox ® FreeHands HME Moist / Flow are designed to allow automatic tracheostoma closure for voice prosthesis users while providing heat and moisture exchange for pulmonary rehabilitation. FDA UDI
Model / Reference
Flow FDA UDI
Description
Provox ® FreeHands HME Moist / Flow are designed to allow automatic tracheostoma closure for voice prosthesis users while providing heat and moisture exchange for pulmonary rehabilitation. FDA UDI

Identifiers

Catalog Number
8223 FDA UDI
Primary DI / UDI-DI
07331791008399 FDA UDI
510(k) Number
K141380 FDA UDI
FDA Product Code
EWL FDA UDI
GMDN Term
Tracheostomy tube speech valve FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3730 FDA UDI
Commercial Distribution
Not 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

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Provox® FreeHands HME® Flow by Atos Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K141380 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Atos Medical Inc.

Sources (1)

  • FDA UDI 1007fda6-83a4-4546-83d5-8309f9bd4e47 38 fields · synced Jun 8, 2026