Provox Life Oxygen (10 pcs) 7620

GUDID 07331791181153

Atos Medical AB

Tracheostoma device adaptor, single-use
Primary Device ID07331791181153
NIH Device Record Key75b2792e-b562-4c25-9340-b6fca056b883
Commercial Distribution StatusIn Commercial Distribution
Brand NameProvox Life Oxygen (10 pcs)
Version Model Number7620
Catalog Number7620
Company DUNS355470923
Company NameAtos Medical AB
Device Count10
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 Datefalse
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from rain. Keep away from sunlight.

Device Identifiers

Device Issuing AgencyDevice ID
GS107331791018107 [Primary]
GS107331791181153 [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 Date2025-12-24
Device Publish Date2025-12-16

Devices Manufactured by Atos Medical AB

07331791181153 - Provox Life Oxygen (10 pcs)2025-12-24
07331791181153 - Provox Life Oxygen (10 pcs)2025-12-24
07331791181160 - Provox Life Oxygen (30 pcs)2025-12-24
07331791181177 - Provox Dilator 172025-07-09
07331791181184 - Provox Dilator 202025-07-09
07331791181191 - Provox Dilator2025-02-17
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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.