TrachPhone (5 pcs) 7723

GUDID 07331791015854

For patients breathing spontaneously via an ET tube or a tracheostomy tube in the hospital or at home.

Atos Medical AB

Tracheostoma protective filter
Primary Device ID07331791015854
NIH Device Record Keyfb02fdb1-cbcc-4194-9e4a-79ee4c40454e
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrachPhone (5 pcs)
Version Model Number7723
Catalog Number7723
Company DUNS355470923
Company NameAtos Medical AB
Device Count5
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
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
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
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 away from rain. 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 away from rain. 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 away from rain. 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 away from rain. 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 away from rain. 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 away from rain. 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 away from rain. 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 away from rain. 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 away from rain. 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 away from rain. 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 away from rain. 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 away from rain. Keep away from sunlight.
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 42 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107331791015854 [Primary]
GS107331791017100 [Unit of Use]
GS107331791101649 [Unit of Use]

FDA Product Code

BYDCondenser, Heat And Moisture (Artificial Nose)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-27
Device Publish Date2023-06-19

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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