Atos Medical 2010-15

GUDID 00817126020313

Laryngectomy Pulmonary Kit 12/55 With Provox® Standard LaryTube™

ATOS MEDICAL INC.

Tracheoesophageal speech valve, indwelling, sterile

• Primary Device ID: 00817126020313
• NIH Device Record Key: 00a26585-dc40-4817-981a-50030b862c8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atos Medical
• Version Model Number: 12/55
• Catalog Number: 2010-15
• Company DUNS: 008224748
• Company Name: ATOS MEDICAL INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: true
• 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: 800-217-0025
• Email: info.us@atosmedical.com
• Phone: 800-217-0025
• Email: info.us@atosmedical.com
• Phone: 800-217-0025
• Email: info.us@atosmedical.com
• Phone: 800-217-0025
• Email: info.us@atosmedical.com
• Phone: 800-217-0025
• Email: info.us@atosmedical.com
• Phone: 800-217-0025
• Email: info.us@atosmedical.com
• Phone: 800-217-0025
• Email: info.us@atosmedical.com
• Phone: 800-217-0025
• Email: info.us@atosmedical.com
• Phone: 800-217-0025
• Email: info.us@atosmedical.com
• Phone: 800-217-0025
• Email: info.us@atosmedical.com
• Phone: 800-217-0025
• Email: info.us@atosmedical.com
• Phone: 800-217-0025
• Email: info.us@atosmedical.com
• Phone: 800-217-0025
• Email: info.us@atosmedical.com
• Phone: 800-217-0025
• Email: info.us@atosmedical.com
• Phone: 800-217-0025
• Email: info.us@atosmedical.com
• Phone: 800-217-0025
• Email: info.us@atosmedical.com
• Phone: 800-217-0025
• Email: info.us@atosmedical.com
• Phone: 800-217-0025
• Email: info.us@atosmedical.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 108 Degrees Fahrenheit
• 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	00817126020313 [Primary]

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-12-20

On-Brand Devices [Atos Medical]

• 00817126020863: 2010-13 Laryngectomy Pulmonary Kit With Standard Provox® LaryTubeâ„¢ 12/27
• 00817126020856: 2010-063 Laryngectomy Pulmonary Kit with Standard Provox® LaryTubeâ„¢ 9/55 and SolaTone Plusâ„¢
• 00817126020849: 2010-062 Laryngectomy Pulmonary Kit with Standard Provox® LaryTubeâ„¢ 10/55 and Vega Voice Pros
• 00817126020832: 2010-061 Laryngectomy Pulmonary Kit with Standard Provox® LaryTubeâ„¢ 10/55 and Vega Voice Pros
• 00817126020795: 2010C2-07E6 Laryngectomy Pulmonary Kit with Standard Provox® LaryTubeâ„¢ 9/55 and Libertyâ„¢ El
• 00817126020788: 2010C4-02 Laryngectomy Pulmonary Kit with Standard Provox® LaryTubeâ„¢ 9/55
• 00817126020702: 2010-053 Laryngectomy Pulmonary Kit with Standard Provox® LaryTubeâ„¢ 12/55 and TruTone Plus®
• 00817126020696: 2010-060 Laryngectomy Pulmonary Kit with Standard Provox® LaryTubeâ„¢ 9/55 and TruTone Plus® E
• 00817126020689: 2010-059 Laryngectomy Pulmonary Kit with Standard Provox® LaryTubeâ„¢ 10/55 and Libertyâ„¢ Elec
• 00817126020672: 2010-03E1 Laryngectomy Pulmonary Kit with Standard Provox® LaryTubeâ„¢ 8/55 and TruTone® Elect
• 00817126020665: 2010-02E1 Laryngectomy Pulmonary Kit with Standard Provox® LaryTubeâ„¢ 8/36 and TruTone® Elect
• 00817126020658: 2010-058 Laryngectomy Pulmonary Kit 9/55 With Provox® Standard LaryTubeâ„¢ & TruToneâ„¢ Electro
• 00817126020641: 2010C2-44E6 Laryngectomy Pulmonary Kit 10/55 With Provox® Fenestrated LaryTubeâ„¢ and Libertyâ„
• 00817126020634: 2010C2-44E6 Laryngectomy Pulmonary Kit 10/55 With Provox® Standard LaryTubeâ„¢ and Libertyâ„¢ E
• 00817126020610: 2010-057 Laryngectomy Pulmonary Kit 10/55 With Provox® Standard LaryTubeâ„¢ and SolaTone® Elec
• 00817126020603: 2010-056 Laryngectomy Pulmonary Kit 9/36 With Provox® Standard LaryTubeâ„¢ and SolaTone® Elect
• 00817126020597: 2010-055 Laryngectomy Pulmonary Kit With SolaTone® Electrolarynx
• 00817126020580: 2010-054 Laryngectomy Pulmonary Kit 12/36 With Provox® Standard LaryTube
• 00817126020573: 2010-41E6 Laryngectomy Pulmonary Kit 9/55 With Provox® Standard LaryTubeâ„¢ and Libertyâ„¢ Elec
• 00817126020566: 2010C-02 Laryngectomy Pulmonary Kit 9/55 With Provox® Standard LaryTubeâ„¢
• 00817126020559: Custom Laryngectomy Pulmonary Kit 10/36 With Provox® Standard LaryTubeâ„¢
• 00817126020542: Custom Laryngectomy Pulmonary Kit 12/55 With Provox® Standard LaryTubeâ„¢ & TruToneâ„¢ Electrol
• 00817126020535: Custom Laryngectomy Pulmonary Kit 10/55 With Provox® Standard LaryTubeâ„¢
• 00817126020528: Laryngectomy Pulmonary Kit 9/55 With Provox® Standard LaryTubeâ„¢ and Libertyâ„¢ Electrolarynx
• 00817126020511: Laryngectomy Pulmonary Kit 9/55 With Provox® LaryTubeâ„¢ with Ring and Provox® OptiDermâ„¢ Adh
• 00817126020504: Laryngectomy Pulmonary Kit 8/36 With Provox® Standard LaryTubeâ„¢
• 00817126020498: Laryngectomy Pulmonary Kit 10/36 With Provox® Standard LaryTubeâ„¢
• 00817126020481: Custom Laryngectomy Pulmonary Kit With Provox® XtraFlowâ„¢ HME
• 00817126020474: Laryngectomy Pulmonary Kit 10/55 With Provox® Standard LaryTubeâ„¢ and TruToneâ„¢ Electrolaryn
• 00817126020467: Laryngectomy Pulmonary Kit With Provox® OptiDermâ„¢ Adhesive
• 00817126020450: Custom Laryngectomy Pulmonary Kit 10/55 With Provox® Standard LaryTubeâ„¢
• 00817126020443: Laryngectomy Pulmonary Kit 10/55 With Provox® Fenestrated LaryTubeâ„¢
• 00817126020436: Laryngectomy Pulmonary Kit With Standard Provox® LaryTubeâ„¢ 9/27
• 00817126020429: Laryngectomy Pulmonary Kit 12/36 With Provox® Standard LaryTubeâ„¢
• 00817126020412: Laryngectomy Pulmonary Kit 9/55 With Provox® Standard LaryTubeâ„¢ and Servoxâ„¢ Electrolarynx
• 00817126020405: Laryngectomy Pulmonary Kit 10/55 With Provox® Standard LaryTubeâ„¢ and TruToneâ„¢ Electrolaryn
• 00817126020382: Laryngectomy Pulmonary Kit 09/36 With Provox® Standard LaryTubeâ„¢ and Libertyâ„¢ Electrolarynx
• 00817126020375: Laryngectomy Pulmonary Kit 9/55 With Provox® Standard LaryTubeâ„¢ and TruToneâ„¢ Electrolarynx
• 00817126020368: Laryngectomy Pulmonary Kit 9/36 With Provox® Standard LaryTubeâ„¢ and TruToneâ„¢ Electrolarynx
• 00817126020351: Laryngectomy Pulmonary Kit 12/55 With Provox® Standard LaryTubeâ„¢ and Libertyâ„¢ Electrolarynx
• 00817126020344: Laryngectomy Pulmonary Kit 9/55 With Provox® Standard LaryTubeâ„¢
• 00817126020337: Laryngectomy Pulmonary Kit 10/36 With Provox® Standard LaryTubeâ„¢ and TruToneâ„¢ Electrolaryn
• 00817126020320: Laryngectomy Pulmonary Kit 10/36 With Provox® Standard LaryTubeâ„¢
• 00817126020313: Laryngectomy Pulmonary Kit 12/55 With Provox® Standard LaryTubeâ„¢
• 00817126020306: Laryngectomy Pulmonary Kit 9/55 With Provox® Standard LaryTubeâ„¢ and Libertyâ„¢ Electrolarynx
• 00817126020290: Laryngectomy Pulmonary Kit 10/55 With Provox® Standard LaryTubeâ„¢
• 00817126020283: Laryngectomy Pulmonary Kit 10/55 With Provox® Standard LaryTubeâ„¢ and Libertyâ„¢ Electrolarynx
• 00817126020276: Laryngectomy Pulmonary Kit 10/36 With Provox® Standard LaryTubeâ„¢ and Libertyâ„¢ Electrolarynx
• 00817126020269: Laryngectomy Pulmonary Kit 9/36 With Provox® Standard LaryTubeâ„¢ and Libertyâ„¢ Electrolarynx
• 00817126020252: Laryngectomy Pulmonary Kit 12/55 With Provox® Fenestrated LaryTubeâ„¢