FDA.reportPublic FDA data

Provox® Life LP Kit 5 - LT 8/36, 8/55

Primary DI
07331791015410
Brand
Provox® Life LP Kit 5 - LT 8/36, 8/55
Company
Atos Medical AB
Model
6134
Device description
Provox Laryngectomy Kits provide all-in-one packaging for immediate post-operative 24/7 pulmonary rehabilitation and the option for ready-to-use surgical placement. The kits feature Provox Heat and Moisture Exchangers (HMEs) – approved for 24-hour use. These products are packed in a box and contain marketing materials and a mix of the following final products (configuration dependent): Provox Life LaryTube, Provox Life Home HME, Provox Life Night HME, Freevent Neckband two-piece L, Provox TubeBrush (8mm), Provox Life Shower, Provox SolaTone Plus, TruTone Plus
Published
2021-05-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OGWTracheostomy Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGWTracheostomy KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07331791015410PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07331791015410073317910154107331791015410

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostoma protective filterA non-sterile device designed as a filter for protecting a stomal opening in the windpipe (surgically-created artificial opening between the trachea and the body surface through which the patient can breathe) against harmful external influences. It may also function as a heat & moisture exchanger (HME) intended to capture the patient's exhaled breath so that it can be used to warm and moisten inspired air to help keep the trachea lubricated and prevent its mucosa from drying. It is typically designed as a hydrophobic foam filter of various sizes held in place with an adhesive strip. This is a single-use device changed regularly according to the manufacturer's instructions.

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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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