Atos Medical Inc. 2010-072

GUDID 00817126020979

2010-072 Laryngectomy Pulmonary Kit with Standard Provox® LaryTube™ 9/36 and SolaTone Plus™ Electrolarynx

ATOS MEDICAL INC.

Transcervical artificial larynx

• Primary Device ID: 00817126020979
• NIH Device Record Key: 0d417d28-eb76-44ab-ad97-7e0ee910d476
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atos Medical Inc.
• Version Model Number: 2010-072
• Catalog Number: 2010-072
• Company DUNS: 008224748
• Company Name: ATOS MEDICAL INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-217-0025
• Email: info.us@atosmedical.com
• Phone: 1-800-217-0025
• Email: info.us@atosmedical.com
• Phone: 1-800-217-0025
• Email: info.us@atosmedical.com
• Phone: 1-800-217-0025
• Email: info.us@atosmedical.com
• Phone: 1-800-217-0025
• Email: info.us@atosmedical.com
• Phone: 1-800-217-0025
• Email: info.us@atosmedical.com
• Phone: 1-800-217-0025
• Email: info.us@atosmedical.com
• Phone: 1-800-217-0025
• Email: info.us@atosmedical.com
• Phone: 1-800-217-0025
• Email: info.us@atosmedical.com
• Phone: 1-800-217-0025
• Email: info.us@atosmedical.com
• Phone: 1-800-217-0025
• Email: info.us@atosmedical.com
• Phone: 1-800-217-0025
• Email: info.us@atosmedical.com
• Phone: 1-800-217-0025
• Email: info.us@atosmedical.com
• Phone: 1-800-217-0025
• Email: info.us@atosmedical.com
• Phone: 1-800-217-0025
• Email: info.us@atosmedical.com
• Phone: 1-800-217-0025
• Email: info.us@atosmedical.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not store in direct sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not store in direct sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not store in direct sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not store in direct sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not store in direct sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not store in direct sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not store in direct sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not store in direct sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not store in direct sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not store in direct sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not store in direct sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not store in direct sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not store in direct sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not store in direct sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not store in direct sunlight.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817126020979 [Primary]

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: 2019-10-03
• Device Publish Date: 2019-09-25

Devices Manufactured by ATOS MEDICAL INC.

• 00817126021006 - Atos Medical Inc: 2020-02-21 Laryngectomy Pulmonary Kit with Standard Provox LaryTube 9/55 and SolaTone Plus Electrolarynx
• 00817126021013 - Atos Medical Inc: 2020-02-21 Laryngectomy Pulmonary Kit with Standard Provox LaryTube 10/55 and SolaTone Plus Electrolarynx
• 00817126020993 - Atos Medical: 2019-12-30 2010-074 Laryngectomy Pulmonary Kit with Standard Provox® LaryTube™ 9/36 and Provox® XtraFlow™ HME
• 00817126020986 - Atos Medical Inc: 2019-12-27 2010-073 Laryngectomy Pulmonary Kit with Standard Provox® LaryTube™ 10/55 and SolaTone Plus™ Electrolarynx
• 00817126020979 - Atos Medical Inc.: 2019-10-032010-072 Laryngectomy Pulmonary Kit with Standard Provox® LaryTube™ 9/36 and SolaTone Plus™ Electrolarynx
• 00817126020979 - Atos Medical Inc.: 2019-10-03 2010-072 Laryngectomy Pulmonary Kit with Standard Provox® LaryTube™ 9/36 and SolaTone Plus™ Electrolarynx
• 00817126020962 - Atos Medical: 2019-08-15 2010-071 Laryngectomy Pulmonary Kit with Liberty® Electrolarynx
• 00817126020955 - Atos Medical: 2019-06-14 2010-070 Laryngectomy Pulmonary Kit with Standard Provox® LaryTube™ 9/55 and TruTone EMOTE® Electrolarynx
• 00817126020948 - Atos Medical: 2019-05-03 2010-069 Laryngectomy Pulmonary Kit with Standard Provox® LaryTube™ 9/55 and Provox® XtraFlow™ HME