Jada™ System JADA-1001

GUDID 00850017882003

Jada™ System Vacuum-induced Hemorrhage Control System

Alydia Health, Inc.

Intrauterine haemostatic suction catheter

• Primary Device ID: 00850017882003
• NIH Device Record Key: 67159057-9925-4655-9709-241b1647efb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Jada™ System
• Version Model Number: JADA-1001
• Catalog Number: JADA-1001
• Company DUNS: 077887522
• Company Name: Alydia Health, 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 (844) 523-2666
• Email: cs@alydiahealth.com
• Phone: +1 (844) 523-2666
• Email: cs@alydiahealth.com
• Phone: +1 (844) 523-2666
• Email: cs@alydiahealth.com
• Phone: +1 (844) 523-2666
• Email: cs@alydiahealth.com
• Phone: +1 (844) 523-2666
• Email: cs@alydiahealth.com
• Phone: +1 (844) 523-2666
• Email: cs@alydiahealth.com
• Phone: +1 (844) 523-2666
• Email: cs@alydiahealth.com
• Phone: +1 (844) 523-2666
• Email: cs@alydiahealth.com
• Phone: +1 (844) 523-2666
• Email: cs@alydiahealth.com
• Phone: +1 (844) 523-2666
• Email: cs@alydiahealth.com
• Phone: +1 (844) 523-2666
• Email: cs@alydiahealth.com
• Phone: +1 (844) 523-2666
• Email: cs@alydiahealth.com
• Phone: +1 (844) 523-2666
• Email: cs@alydiahealth.com
• Phone: +1 (844) 523-2666
• Email: cs@alydiahealth.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep Dry. Do not use if package is damaged and consult instructions for use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep Dry. Do not use if package is damaged and consult instructions for use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep Dry. Do not use if package is damaged and consult instructions for use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep Dry. Do not use if package is damaged and consult instructions for use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep Dry. Do not use if package is damaged and consult instructions for use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep Dry. Do not use if package is damaged and consult instructions for use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep Dry. Do not use if package is damaged and consult instructions for use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep Dry. Do not use if package is damaged and consult instructions for use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep Dry. Do not use if package is damaged and consult instructions for use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep Dry. Do not use if package is damaged and consult instructions for use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep Dry. Do not use if package is damaged and consult instructions for use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep Dry. Do not use if package is damaged and consult instructions for use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep Dry. Do not use if package is damaged and consult instructions for use.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep Dry. Do not use if package is damaged and consult instructions for use.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850017882003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201199

FDA Product Code

• OQY: Intrauterine Tamponade Balloon

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: 2020-10-23
• Device Publish Date: 2020-10-15