Provox Adhesive - Provox StabiliBase adhesive is a single use - Atos Medical AB

Duns Number:355470923

Device Description: Provox StabiliBase adhesive is a single use device intended for laryngectomized patients b Provox StabiliBase 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 for components of the Provox HME System. The design of the StabiliBase adapter can be especially suitable for deep tracheostomas.

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More Product Details

Catalog Number

7318

Brand Name

Provox Adhesive

Version/Model Number

StabiliBase OptiDerm

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KGX

Product Code Name

Tape And Bandage, Adhesive

Device Record Status

Public Device Record Key

1b92cd4f-233b-4fb0-9177-8a6b929871b5

Public Version Date

July 21, 2022

Public Version Number

1

DI Record Publish Date

July 13, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ATOS MEDICAL AB" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 119
2 A medical device with a moderate to high risk that requires special controls. 169