FDA.reportPublic FDA data

Provox XtraFlow HME (30 pcs)

Primary DI
07331791016332
Brand
Provox XtraFlow HME (30 pcs)
Company
Atos Medical AB
Model
7291
Catalog number
7291
Device description
The Provox XtraHME Cassette is a single use, specialized device intended for patients breathing through a tracheostoma. It is a heat and moisture exchanger (HME) that heats and humidifies inhaled air by retaining heat and moist from exhaled air in the device. It partially restores lost breathing resistance. For patients with a voice prosthesis or surgical speech fistula it may also facilitate voicing.
Published
2022-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYDCondenser, Heat And Moisture (Artificial Nose)
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYDCondenser, Heat And Moisture (Artificial Nose)Anesthesiology1
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07331791017735PackageGS150In Commercial Distribution
07331791005909PrimaryGS10
07331791015670PrimaryGS10
07331791016332Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07331791017735073317910177357331791017735
07331791005909073317910059097331791005909
07331791015670073317910156707331791015670
07331791016332073317910163327331791016332

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
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
30
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07331791008320HME DigiTop O2775677562022-12-07
07331791015564Provox Life Coming Home USA8224US218224US212022-11-29
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
07331791014451Provox Life Sensitive Adhesive Round746374632022-07-13
07331791014468Provox Life Sensitive Adhesive Oval746474642022-07-13
07331791014475Provox Life Sensitive Adhesive Oval B746574652022-07-13

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Primary DI, Brand, Company table
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