SPIRO 710-1K; 710-2K; 710-5K

GUDID 07350061231121

SPIRO Speaking Valve With Oxygen Nipple

Fogless International AB

Tracheostomy tube speech valve

• Primary Device ID: 07350061231121
• NIH Device Record Key: 65044665-f02f-46e7-aaa5-7f7c6f48d1db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPIRO
• Version Model Number: 710
• Catalog Number: 710-1K; 710-2K; 710-5K
• Company DUNS: 356432815
• Company Name: Fogless International AB
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se
• Phone: +4636144100
• Email: mail@fogless.se

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dark and dry environment at normal indoor room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350061231121 [Primary]
GS1	07350061231138 [Package]; Package: Paper Carton [2 Units]; In Commercial Distribution
GS1	07350061231145 [Package]; Package: Paper Carton [5 Units]; In Commercial Distribution
GS1	07350061231367 [Package]; Package: Paper Carton [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122932

FDA Product Code

• JOH: Tube Tracheostomy And Tube Cuff

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-08-23
• Device Publish Date: 2018-03-31

On-Brand Devices [SPIRO]

• 07350061231350: SPIRO Filter
• 07350061231282: SPIRO Basic Set Humidifier
• 07350061231268: SPIRO Basic Set Speaking Valve
• 07350061231237: Shower Protection for SPIRO Speaking Valve models 710,710R,711
• 07350061231183: SPIRO Speaking Valve Without Oxygen Nipple
• 07350061231152: SPIRO Speaking Valve With Oxygen Nipple (Red)
• 07350061231121: SPIRO Speaking Valve With Oxygen Nipple
• 07350061231114: SPIRO Adapter (white) 14mm for SPIRO 702, 710, 710R and 711 to connect to a non ISO 15 tapered c
• 07350061231091: SPIRO Adapter (transparent) 13mm for SPIRO 702, 710, 710R and 711 to connect to a non ISO 15 tap
• 07350061231077: SPIRO Tweezers
• 07350061231046: Shower Protector for SPIRO 702 Humidifier
• 07350061231008: SPIRO 702 Humidifier
• 07350061230353: XXX