FDA.report

Provox Life LaryButton

Primary DI
07331791015304
Brand
Provox Life LaryButton
Company
Atos Medical AB
Model
12/8
Catalog number
8040
Device description
Provox Life LaryButton is a single patient use self-retaining holder for Provox Life HMEs and accessories after total laryngectomy. For patients with a shrinking tracheostomas it is also used to maintain the tracheostoma for breathing. Provox Life LaryButton is intended for single patient use.
Published
2022-07-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KACTube, Laryngectomy

Product Code Classifications

CodeDeviceSpecialtyClass
KACTube, LaryngectomyEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07331791015304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07331791015304073317910153047331791015304

GMDN Terms

TermDefinition
Tracheostoma buttonA hollow device intended to be used routinely by a patient to prevent the narrowing of a tracheostoma during intermittent use of their tracheostomy or laryngectomy tube. It is a cylindrical synthetic polymer device designed for minimal intrusion beyond the tracheostomal orifice into which it is placed. This is a reusable device.

Device Sizes

TypeValueUnit
Length8Millimeter
Lumen/Inner Diameter9.5Millimeter
Outer Diameter12Millimeter

Storage And Handling

TypeLowHighCondition
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

Contacts

PhoneEmail
+4641519800info@atosmedical.com

Regulatory Flags

DUNS number
355470923
Device count
1
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

Other Devices From This Company

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07331791181238Provox Life Comfort Adhesive Oval840384032026-01-16
07331791181276Provox Life Comfort Experience Oval809480942026-01-16
07331791181153Provox Life Oxygen (10 pcs)762076202025-12-16
07331791181160Provox Life Oxygen (30 pcs)762176212025-12-16
07331791181177Provox Dilator 17834283422025-07-01
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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