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Provox StabiliBase OptiDerm (3pcs)

FDA UDI

Class I (US FDA UDI)

by Atos Medical Inc.

Identity

Trade Name
Provox StabiliBase OptiDerm (3pcs) FDA UDI
Generic Name
Removable ambulatory appliance skin-adherent patch FDA UDI
Device Name
Provox StabiliBase OptiDerm adhesive is a single use device intended for laryngectomized patients breathing through a tracheostoma. The device is attached to the skin around the tracheostoma in order to provide attachment of components of the Provox HME System. FDA UDI
Model / Reference
7328 FDA UDI
Description
Provox StabiliBase OptiDerm adhesive is a single use device intended for laryngectomized patients breathing through a tracheostoma. The device is attached to the skin around the tracheostoma in order to provide attachment of components of the Provox HME System. FDA UDI

Identifiers

Catalog Number
7328 FDA UDI
Primary DI / UDI-DI
07331791009044 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
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

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

Provox StabiliBase OptiDerm (3pcs) by Atos Medical Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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 13e0cce5-9360-4f33-8847-58fef32bfd9a 37 fields · synced May 29, 2026