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Provox Life Coming Home USA

FDA UDI

Class I (US FDA UDI)

by Atos Medical Inc.

Identity

Trade Name
Provox Life Coming Home USA FDA UDI
Generic Name
Tracheostoma protective filter FDA UDI
Device Name
Provox Coming Home/Provox Life Coming Home is an assortment of products and information for newly laryngectomized persons. It provides guidance on product use, lung rehabilitation, and stoma care at home. FDA UDI
Model / Reference
8224US21 FDA UDI
Description
Provox Coming Home/Provox Life Coming Home is an assortment of products and information for newly laryngectomized persons. It provides guidance on product use, lung rehabilitation, and stoma care at home. FDA UDI

Identifiers

Catalog Number
8224US21 FDA UDI
Primary DI / UDI-DI
07331791015564 FDA UDI
FDA Product Code
BYD FDA UDI
GMDN Term
Tracheostoma protective filter FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.5375 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

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Tracheostoma protective filter

Provox Life Coming Home USA by Atos Medical Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tracheostoma protective filter.

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 ea2e7ad9-f521-4d51-886d-5a39d4e51ebe 36 fields · synced May 31, 2026