Atos Medical Inc 2010-073

GUDID 00817126020986

2010-073 Laryngectomy Pulmonary Kit with Standard Provox® LaryTube™ 10/55 and SolaTone Plus™ Electrolarynx

ATOS MEDICAL INC.

Basic tracheostomy tube, reusable

• Primary Device ID: 00817126020986
• NIH Device Record Key: 63cf8c22-b552-40bb-a009-a87fdc67f2d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atos Medical Inc
• Version Model Number: 2010-073
• Catalog Number: 2010-073
• 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

• Storage 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.
• Storage 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.
• Storage 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.
• Storage 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.
• Storage 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.
• Storage 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.
• Storage 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.
• Storage 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.
• Storage 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.
• Storage 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.
• Storage 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.
• Storage 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.
• Storage 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.
• Storage 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.
• Storage 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.
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817126020986 [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: 2019-12-27
• Device Publish Date: 2019-12-19

On-Brand Devices [Atos Medical Inc]

• 00817126021013: Laryngectomy Pulmonary Kit with Standard Provox LaryTube 10/55 and SolaTone Plus Electrolarynx
• 00817126021006: Laryngectomy Pulmonary Kit with Standard Provox LaryTube 9/55 and SolaTone Plus Electrolarynx
• 00817126020986: 2010-073 Laryngectomy Pulmonary Kit with Standard Provox® LaryTubeâ„¢ 10/55 and SolaTone Plusâ„