FDA.report

Provox Tracheofix

Primary DI
07331791016820
Brand
Provox Tracheofix
Company
Atos Medical AB
Model
1 strip ivory 70x70
Catalog number
1428
Device description
Provox Tracheofix is a single-use foam protector intended to absorb secretions and to provide protection and aesthetic coverage of the tracheostoma.
Published
2022-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NACDressing, Wound, Hydrophilic

Product Code Classifications

CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07331791012457PrimaryGS10
07331791016820Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07331791012457073317910124577331791012457
07331791016820073317910168207331791016820

GMDN Terms

TermDefinition
Tracheostoma protector, single-useA patient-worn device in the form of a self-adhesive patch designed to protect a tracheostoma orifice against harmful external influences and to absorb secretions; it may also act as a tracheal air filter. It is typically made of porous textile, foam or synthetic fabric materials; it is not intended to be used as a shower shield. This is a single-use device.

Device Sizes

TypeValueUnit
Height70Millimeter
Width70Millimeter

Storage And Handling

TypeLowHighCondition
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

Contacts

PhoneEmail
+4641519800info@atosmedical.com

Regulatory Flags

DUNS number
355470923
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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07331791181153Provox Life Oxygen (10 pcs)762076202025-12-16
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07331791181184Provox Dilator 20834383432025-07-01
07331791181191Provox Dilator834183412025-02-08
07331791016905Provox Adhesive OptiDerm Round725572552022-07-13
07331791016929Provox XtraBase Adhesive726572652022-07-13
07331791016899Provox Adhesive FlexiDerm Plus733173312022-07-13
07331791016912Provox Adhesive OptiDerm Plus733273322022-07-13
07331791016943Provox Life Go HME831083102022-12-07
07331791016950Provox Life Home HME831183112022-12-07
07331791016967Provox Life Energy HME831283122022-12-07
07331791016974Provox Life Protect HME831383132022-12-07
07331791017124Freevent XtraCare Mini Blue (30 pcs)800580052023-12-04
07331791017131Freevent XtraCare Mini Pink (30 pcs)800680062023-12-04
07331791017148Freevent XtraCare Mini White (5 pcs)800880082023-12-04
07331791017155Freevent O2 Adaptor Mini (10 pcs)800780072023-12-04
07331791017001Provox Life Standard Experience Round806580652022-11-29

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