Freevent DualCare - Freevent DualCare is a combined speaking valve - Atos Medical AB

Duns Number:355470923

Device Description: Freevent DualCare is a combined speaking valve and heat & moisture exchanger (HME) intende Freevent DualCare is a combined speaking valve and heat & moisture exchanger (HME) intended for tracheostomized patients using a tracheostomy tube. In HME-mode the device conditions inhaled air by retaining heat and moisture from the exhaled air. By turning the lid of the speaking valve into speaking mode air is re-directed to enable speech.

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More Product Details

Catalog Number

7741

Brand Name

Freevent DualCare

Version/Model Number

Set 15

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K151404,K151404

Product Code Details

Product Code

JOH

Product Code Name

Tube Tracheostomy And Tube Cuff

Device Record Status

Public Device Record Key

8a97d197-4f48-4e9b-b6aa-1b067c88be99

Public Version Date

July 18, 2022

Public Version Number

3

DI Record Publish Date

May 29, 2020

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