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Provox Life Sensitive Experience Round

FDA UDI

Class I (US FDA UDI)

by Atos Medical Inc.

Identity

Trade Name
Provox Life Sensitive Experience Round FDA UDI
Generic Name
Removable ambulatory appliance skin-adherent patch FDA UDI
Device Name
Provox Life Adhesives are single use adhesives that provide attachment for Provox Life HMEs and accessories after total laryngectomy FDA UDI
Model / Reference
8068 FDA UDI
Description
Provox Life Adhesives are single use adhesives that provide attachment for Provox Life HMEs and accessories after total laryngectomy FDA UDI

Identifiers

Catalog Number
8068 FDA UDI
Primary DI / UDI-DI
07331791015687 FDA UDI
FDA Product Code
KGX FDA UDI
GMDN Term
Removable ambulatory appliance skin-adherent patch FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.5240 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

Category: Removable ambulatory appliance skin-adherent patch

Provox Life Sensitive Experience Round by Atos Medical Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Removable ambulatory appliance skin-adherent patch.

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 40807493-a86e-4318-bfbc-a8cd50b86998 36 fields · synced Jun 6, 2026