Provox Adhesive 7256

GUDID 07331791016424

The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices are attached to the skin around the tracheostoma in order to provide attachment for components of the Provox HME System.

Atos Medical AB

Stomal appliance skin-adherent patch, non-sterile
Primary Device ID07331791016424
NIH Device Record Key35a103a1-1b2a-47e3-a0cb-9b8e9770ac2a
Commercial Distribution StatusIn Commercial Distribution
Brand NameProvox Adhesive
Version Model NumberOptiDerm Oval
Catalog Number7256
Company DUNS355470923
Company NameAtos Medical AB
Device Count20
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight.

Device Identifiers

Device Issuing AgencyDevice ID
GS107331791001642 [Primary]
GS107331791016424 [Unit of Use]

FDA Product Code

KGXTape And Bandage, Adhesive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-21
Device Publish Date2022-07-13

On-Brand Devices [Provox Adhesive]

07331791016486Provox Adhesive Strip is a single use device to seal Provox adhesives, e.g. during showering.
07331791016462Provox StabiliBase adhesive is a single use device intended for laryngectomized patients breathi
07331791016431The Provox Adhesives are single use devices intended for laryngectomized patients breathing thro
07331791016400The Provox Adhesives are single use devices intended for laryngectomized patients breathing thro
07331791016455Provox StabiliBase adhesive is a single use device intended for laryngectomized patients breathi
07331791016448The Provox Adhesives are single use devices intended for laryngectomized patients breathing thro
07331791016424The Provox Adhesives are single use devices intended for laryngectomized patients breathing thro
07331791016417The Provox Adhesives are single use devices intended for laryngectomized patients breathing thro
07331791016394The Provox Adhesives are single use devices intended for laryngectomized patients breathing thro
07331791016387The Provox Adhesives are single use devices intended for laryngectomized patients breathing thro

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