Provox Wipes 8243

GUDID 07331791010392

Provox Skin Barrier is a single use wipe for laryngectomized patients that forms a barrier between Provox Adhesive and the skin.Provox Cleaning Towel is intended for cleaning around the stoma, it will remove oil from the skin. They are indented to use before application of Provox Adhesives. Provox Adhesive Remover is a single use wipe to help laryngectomized patients remove Provox Adhesives and Provox Silicone Glue.

Atos Medical AB

Synthetic-polymer liquid barrier dressing, non-sterile
Primary Device ID07331791010392
NIH Device Record Key7bd35d23-abe1-4e21-bd23-20b00fd132ba
Commercial Distribution StatusIn Commercial Distribution
Brand NameProvox Wipes
Version Model Number8243
Catalog Number8243
Company DUNS355470923
Company NameAtos Medical AB
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kittrue
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
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com
Phone+4641519800
Emailinfo@atosmedical.com

Operating and Storage Conditions

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
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 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
GS107331791010392 [Primary]

FDA Product Code

NECBandage, Liquid, Skin Protectant

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-02
Device Publish Date2022-11-24

Devices Manufactured by Atos Medical AB

07331791016905 - Provox Adhesive OptiDerm Round2024-11-29 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices
07331791016929 - Provox XtraBase Adhesive2024-11-25 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices
07331791016899 - Provox Adhesive FlexiDerm Plus2024-11-25 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices
07331791016912 - Provox Adhesive OptiDerm Plus2024-11-25 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices
07331791016943 - Provox Life Go HME2024-11-25 Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma.
07331791016950 - Provox Life Home HME2024-11-25 Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma.
07331791016967 - Provox Life Energy HME2024-11-25 Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma.
07331791016974 - Provox Life Protect HME2024-11-25 Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma.

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