Provox Micron HME (30 pcs)

Primary DI
07331791001567
Brand
Provox Micron HME (30 pcs)
Company
Atos Medical AB
Model
7248
Catalog number
7248
Device description
Provox Micron HME is a disposable device that features a calcium chloride-treated foam core in a plastic housing. Provox Micron HME also contains an electrostatic filter material which reduces airborne particles. The filter consists of synthetic fibres which, during the manufacturing process, generate electrical charges on the fibre surface. The result is a highly stable, coarse fibred electrostatic filter media with high efficiency against sub-micron particles and low air flow resistance.The housing of Provox Micron HME can be pressed down to occlude the stoma in order to speak with a voice prosthesis. When the pressure is released, the housing automatically retracts and opens the airway passage.
Published
2016-09-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
K072582000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072582000PROVOX MICRON HMEAtos Medical AB2008-05-30JOH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07331791017773PackageGS18In Commercial Distribution
07331791001567PrimaryGS10
07331791010590Unit of UseGS10
07331791016936Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07331791017773073317910177737331791017773
07331791001567073317910015677331791001567
07331791010590073317910105907331791010590
07331791016936073317910169367331791016936

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
30
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
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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