Provox StabiliBase OptiDerm (3pcs) 7328

GUDID 07331791009044

Provox StabiliBase OptiDerm adhesive is a single use device intended for laryngectomized patients breathing through a tracheostoma. The device is attached to the skin around the tracheostoma in order to provide attachment of components of the Provox HME System.

Atos Medical AB

Removable ambulatory appliance skin-adherent patch Removable ambulatory appliance skin-adherent patch Removable ambulatory appliance skin-adherent patch Removable ambulatory appliance skin-adherent patch Removable ambulatory appliance skin-adherent patch Removable ambulatory appliance skin-adherent patch Removable ambulatory appliance skin-adherent patch Removable ambulatory appliance skin-adherent patch Removable ambulatory appliance skin-adherent patch Removable ambulatory appliance skin-adherent patch Removable ambulatory appliance skin-adherent patch Removable ambulatory appliance skin-adherent patch Removable ambulatory appliance skin-adherent patch Removable ambulatory appliance skin-adherent patch Removable ambulatory appliance skin-adherent patch Removable ambulatory appliance skin-adherent patch Removable ambulatory appliance skin-adherent patch Removable ambulatory appliance skin-adherent patch
Primary Device ID07331791009044
NIH Device Record Key13e0cce5-9360-4f33-8847-58fef32bfd9a
Commercial Distribution StatusIn Commercial Distribution
Brand NameProvox StabiliBase OptiDerm (3pcs)
Version Model Number7328
Catalog Number7328
Company DUNS355470923
Company NameAtos Medical AB
Device Count3
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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107331791009044 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-11-03
Device Publish Date2022-12-08

Devices Manufactured by Atos Medical AB

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
07331791008023 - Provox StabiliBase (3pcs)2023-11-03 The Provox StabiliBase adhesive is a single use device intended for laryngectomized patients breathing through a tracheostoma. T
07331791009044 - Provox StabiliBase OptiDerm (3pcs)2023-11-03Provox StabiliBase OptiDerm adhesive is a single use device intended for laryngectomized patients breathing through a tracheostoma. The device is attached to the skin around the tracheostoma in order to provide attachment of components of the Provox HME System.
07331791009044 - Provox StabiliBase OptiDerm (3pcs)2023-11-03 Provox StabiliBase OptiDerm adhesive is a single use device intended for laryngectomized patients breathing through a tracheosto
07331791010293 - Provox XtraBase (3pcs)2023-11-03 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices
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
07331791010316 - Provox FlexiDerm Oval (3pcs)2023-11-03 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices
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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