Freevent XtraCare Mini White 8004

GUDID 07331791014901

Freevent XtraCare Mini is a single use Heat and Moisture Exchanger with electrostatic filter (HMEF) that condition and filter inhaled air in patients spontaneously breathing through a tracheostoma.

Atos Medical AB

Tracheostoma protective filter Tracheostoma protective filter Tracheostoma protective filter Tracheostoma protective filter Tracheostoma protective filter Tracheostoma protective filter Tracheostoma protective filter Tracheostoma protective filter Tracheostoma protective filter Tracheostoma protective filter Tracheostoma protective filter Tracheostoma protective filter Tracheostoma protective filter Tracheostoma protective filter Tracheostoma protective filter Tracheostoma protective filter Tracheostoma protective filter
Primary Device ID07331791014901
NIH Device Record Key10a5b808-ef52-4877-986d-60f0e6ae5349
Commercial Distribution StatusIn Commercial Distribution
Brand NameFreevent XtraCare Mini White
Version Model Number8004
Catalog Number8004
Company DUNS355470923
Company NameAtos Medical AB
Device Count30
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 Perscriptiontrue
OTC Over-The-Counterfalse

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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107331791014901 [Primary]
GS107331791016530 [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 Date2023-12-12
Device Publish Date2023-12-04

Devices Manufactured by Atos Medical AB

07331791014901 - Freevent XtraCare Mini White2023-12-12Freevent XtraCare Mini is a single use Heat and Moisture Exchanger with electrostatic filter (HMEF) that condition and filter inhaled air in patients spontaneously breathing through a tracheostoma.
07331791014901 - Freevent XtraCare Mini White2023-12-12 Freevent XtraCare Mini is a single use Heat and Moisture Exchanger with electrostatic filter (HMEF) that condition and filter in
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07331791010309 - Provox FlexiDerm Round (3pcs)2023-11-03 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices
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07331791010323 - Provox OptiDerm Round (3pcs)2023-11-03 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices
07331791010330 - Provox OptiDerm Oval (3pcs)2023-11-03 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices

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