FDA.reportPublic FDA data

Freevent DualCare Speaking Valve

Primary DI
07331791015045
Brand
Freevent DualCare Speaking Valve
Company
Atos Medical AB
Model
7744
Catalog number
7744
Device description
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.
Published
2020-05-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOHTube Tracheostomy And Tube Cuff

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOHTube Tracheostomy And Tube CuffAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151404000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151404000ProTrach DualcareAtos Medical AB2016-02-12JOH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07331791008214PreviousGS10
07331791015045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07331791008214073317910082147331791008214
07331791015045073317910150457331791015045

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy tube speech valveA device designed to be attached to a tracheostomy tube to eliminate the necessity of finger occlusion during speech, enabling the tracheostomized patient to speak easily and more clearly. It is typically intended to be regularly attached and removed by the patient (e.g., before and after sleeping). It may be made of metal [e.g., silver (Ag)] or plastic materials, and some types may have a sideport for connection to an oxygen supply. This is a single-patient device that may be reapplied over a period of time before being discarded.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature36 Degrees Fahrenheit108 Degrees Fahrenheit
Special Storage Condition, Specify00Keep away from rain. Keep away from sunlight.
Special Storage Condition, Specify00Keep dry. Keep away from sunlight.
Storage Environment Temperature2 Degrees Celsius42 Degrees Celsius
Storage Environment Temperature36 Degrees Fahrenheit108 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4641519800info@atosmedical.com

Regulatory Flags#

DUNS number
355470923
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07331791015564Provox Life Coming Home USA8224US218224US212022-11-29
07331791002861TrachPhone (50 pcs)770477042022-11-29
07331791009693TrachPhone (30 pcs)770777072022-11-29
07331791015854TrachPhone (5 pcs)772377232023-06-19
07331791008320HME DigiTop O2775677562022-12-07
07331791001611Provox Adhesive FlexiDerm Round725372532022-07-13
07331791001628Provox Adhesive FlexiDerm Oval725472542022-07-13
07331791001635Provox Adhesive OptiDerm Round725572552022-07-13
07331791001642Provox Adhesive OptiDerm Oval725672562022-07-13
07331791001703Provox XtraBase Adhesive726572652022-07-13
07331791008016Provox StabiliBase (15 pcs)728972892022-07-13
07331791008160Provox Adhesive FlexiDerm Plus733173312022-07-13
07331791008177Provox Adhesive OptiDerm Plus733273322022-07-13
07331791009037Provox StabiliBase OptiDerm (15 pcs)731873182022-07-13
07331791009259Provox Luna Adhesive801480142022-07-13
07331791009303Provox FreeHands Support Adhesive (15 pcs)802480242022-07-13
07331791009525Provox Adhesive Strip801580152022-07-13
07331791014420Provox Life Standard Adhesive Round746074602022-07-13
07331791014437Provox Life Standard Adhesive Oval746174612022-07-13
07331791014444Provox Life Standard Adhesive Plus746274622022-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709207919BivonaICU MEDICAL, INC.JOH2026-10-29
10887709207926BivonaICU MEDICAL, INC.JOH2026-10-29
10887709207735BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207742BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207759BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207766BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207773BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207780BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207797BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207803BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207810BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207827BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207834BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207841BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207858BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207865BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207872BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207285BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207292BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207308BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207315BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207322BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207445BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207452BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207469BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207476BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207483BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207490BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207506BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207513BivonaICU MEDICAL, INC.JOH2026-10-27