FREEVENT Neckband, two-piece, small 1652

GUDID 07331791016639

The Freevent Neckbands are used for holding a tube/button in place by wearing it around the neck and connecting the ends of the neckband to the tube/button.

Atos Medical AB

Tracheostomy tube neck holder, single-use

Primary Device ID	07331791016639
NIH Device Record Key	8df58191-6c65-41dd-a84c-70d788a4b463
Commercial Distribution Status	In Commercial Distribution
Brand Name	FREEVENT Neckband, two-piece, small
Version Model Number	1652
Catalog Number	1652
Company DUNS	355470923
Company Name	Atos Medical AB
Device Count	10
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	MR Safe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	true

Customer Support Contacts

Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com
Phone	+4641519800
Email	info@atosmedical.com

Device Dimensions

Length	25 Centimeter
Length	40 Centimeter
Length	25 Centimeter
Length	40 Centimeter
Length	25 Centimeter
Length	40 Centimeter
Length	25 Centimeter
Length	40 Centimeter
Length	25 Centimeter
Length	40 Centimeter
Length	25 Centimeter
Length	40 Centimeter
Length	25 Centimeter
Length	40 Centimeter
Length	25 Centimeter
Length	40 Centimeter
Length	25 Centimeter
Length	40 Centimeter
Length	25 Centimeter
Length	40 Centimeter
Length	25 Centimeter
Length	40 Centimeter
Length	25 Centimeter
Length	40 Centimeter
Length	25 Centimeter
Length	40 Centimeter
Length	25 Centimeter
Length	40 Centimeter
Length	25 Centimeter
Length	40 Centimeter
Length	25 Centimeter
Length	40 Centimeter
Length	25 Centimeter
Length	40 Centimeter
Length	25 Centimeter
Length	40 Centimeter
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0

Operating and Storage Conditions

Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Special Storage Condition, Specify	Between 0 and 0 *Keep dry. Keep away from sunlight
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
Storage Environment Temperature	Between 2 Degrees Celsius and 42 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Keep away from rain. Keep away from sunlight.
Storage Environment Temperature	Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	07331791012921 [Primary]
GS1	07331791016639 [Unit of Use]

FDA Product Code

CBH	Device, Fixation, Tracheal Tube

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-12-07
Device Publish Date	2022-11-29

Devices Manufactured by Atos Medical AB

07331791016905 - Provox Adhesive OptiDerm Round	2024-11-29 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices
07331791016929 - Provox XtraBase Adhesive	2024-11-25 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices
07331791016899 - Provox Adhesive FlexiDerm Plus	2024-11-25 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices
07331791016912 - Provox Adhesive OptiDerm Plus	2024-11-25 The Provox Adhesives are single use devices intended for laryngectomized patients breathing through a tracheostoma. The devices
07331791016943 - Provox Life Go HME	2024-11-25 Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma.
07331791016950 - Provox Life Home HME	2024-11-25 Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma.
07331791016967 - Provox Life Energy HME	2024-11-25 Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma.
07331791016974 - Provox Life Protect HME	2024-11-25 Provox Life HMEs are single use heat and moisture exchangers for patients breathing through a tracheostoma.