← Back to catalogue

Provox Tracheofix 2 strips beige 70x70

FDA UDIEUDAMED

Class I (US FDA UDI)

by Atos Medical Inc.

Identity

Trade Name
Provox Tracheofix 2 strips beige 70x70 FDA UDI
Generic Name
Tracheostoma protector, single-use FDA UDI
Device Name
Provox Tracheofix is a single-use foam protector intended to absorb secretions and to provide protection and aesthetic coverage of the tracheostoma. FDA UDI
Model / Reference
1433H FDA UDI
Description
Provox Tracheofix is a single-use foam protector intended to absorb secretions and to provide protection and aesthetic coverage of the tracheostoma. FDA UDI

Identifiers

Catalog Number
1433H FDA UDI
Primary DI / UDI-DI
07331791006807 FDA UDI
FDA Product Code
NAC FDA UDI
GMDN Term
Tracheostoma protector, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4018 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

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

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

Dimensions & Sizes

Size
Length — 70 Millimeter FDA UDI
Width — 70 Millimeter FDA UDI

Category: Tracheostoma protector, single-use

Provox Tracheofix 2 strips beige 70x70 by Atos Medical Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Atos Medical Inc.

Sources (2)

  • FDA UDI f8aae9c9-1836-45a9-a263-e7cb211c5506 37 fields · synced Jun 19, 2026
  • EUDAMED 1 fields · synced Jun 19, 2026