The Slide®

GUDID M71004615000

Slide Nylon.

BIOTEX, INC.

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: M71004615000
• NIH Device Record Key: 513f905f-5ecd-40f4-839e-5a982cd01580
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: The Slide®
• Version Model Number: 046-1500
• Company DUNS: 969792050
• Company Name: BIOTEX, INC.
• Device Count: 1
• DM Exempt: false
• 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: true
• Expiration Date: false
• 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: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M71004615000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203712

FDA Product Code

• LQZ: Device, Jaw Repositioning

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: 2023-05-29
• Device Publish Date: 2023-05-19

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• M71003850000 - Bayou™ troCarWash System Controller: 2023-08-14
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• M71004610000 - The Slide™: 2021-09-09