Freevent® HME 15 Regular

GUDID 07331791015083

Freevent HME 15 is a Heat and Moisture Exchanger (HME) intended for spontaneously breathing tracheostomized patients using a tracheostomy tube with a ISO 15 mm connector. The HME conditions inhaled air by retaining heat and moisture from the exhaled air. The device also partially restores lost breathing resistance.

Atos Medical AB

Tracheostomy tube speech valve
Primary Device ID07331791015083
NIH Device Record Keyaeb98928-3ae7-4aa6-a0ef-f5c9258b3490
Commercial Distribution StatusIn Commercial Distribution
Brand NameFreevent® HME 15 Regular
Version Model Number7742
Company DUNS355470923
Company NameAtos Medical AB
Device Count30
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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
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
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

Device Dimensions

Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
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Outer Diameter15 Millimeter
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Outer Diameter15 Millimeter
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Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
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Outer Diameter15 Millimeter
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Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
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Outer Diameter15 Millimeter
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Outer Diameter15 Millimeter
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Outer Diameter15 Millimeter
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Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
Outer Diameter15 Millimeter
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Outer Diameter15 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107331791008207 [Previous]
GS107331791015069 [Primary]
GS107331791015083 [Unit of Use]
GS107331791017841 [Package]
Contains: 07331791015069
Package: Shipper Box [30 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JOHTube Tracheostomy And Tube Cuff

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-08
Device Publish Date2020-05-29

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.

Trademark Results [Freevent]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FREEVENT
FREEVENT
87948161 not registered Live/Pending
ATOS MEDICAL AB
2018-06-04
FREEVENT
FREEVENT
86150132 4846655 Live/Registered
Eddie Bauer Licensing Services LLC
2013-12-20
FREEVENT
FREEVENT
79055091 3658213 Dead/Cancelled
Atos Medical AB
2008-06-19

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