Desara Blue TVez 3.0

GUDID 00890594000124

Desara Blue TVez 3.0mm for the treatment of female stress urinary incontinence (SUI) or mixed incontinence

Caldera Medical, Inc.

Female stress urinary incontinence surgical mesh-sling, synthetic polymer

• Primary Device ID: 00890594000124
• NIH Device Record Key: b7f679de-7d69-42d8-9f5b-afd8a92b2fad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Desara Blue TVez 3.0
• Version Model Number: CAL-DS01BTV30
• Company DUNS: 130341956
• Company Name: Caldera Medical, 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: 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: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com
• Phone: 1-818-879-6555
• Email: hello@calderamedical.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.
• Special Storage Condition, Specify: Between 0 and 0 *Desara Blue TVez is recommended to be stored at room temperature in a clean, dry location.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00890594000124 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211975

FDA Product Code

• OTN: Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-11
• Device Publish Date: 2022-08-03

On-Brand Devices [Desara Blue TVez 3.0]

• 00890594000087: Desara Blue TVez 3.0mm for the treatment of female stress urinary incontinence (SUI) or mixed in
• 00890594000124: Desara Blue TVez 3.0mm for the treatment of female stress urinary incontinence (SUI) or mixed in