Jada™ System JADA-1001

GUDID 00850017882003

Jada™ System Vacuum-induced Hemorrhage Control System

Alydia Health, Inc.

Intrauterine haemostatic suction catheter Intrauterine haemostatic suction catheter Intrauterine haemostatic suction catheter Intrauterine haemostatic suction catheter Intrauterine haemostatic suction catheter Intrauterine haemostatic suction catheter Intrauterine haemostatic suction catheter Intrauterine haemostatic suction catheter Intrauterine haemostatic suction catheter Intrauterine haemostatic suction catheter Intrauterine haemostatic suction catheter Intrauterine haemostatic suction catheter Intrauterine haemostatic suction catheter 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