ABBI

GUDID 00888937014174

ABBI™ (Air Bubble Based Infuser) For office based Sono HSG Procedures

Coopersurgical, Inc.

Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector Uterine injector

• Primary Device ID: 00888937014174
• NIH Device Record Key: 52f00204-cee4-4604-b87a-2d177a291990
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ABBI
• Version Model Number: ABBI
• Company DUNS: 801895244
• Company Name: Coopersurgical, 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888937014174 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143415

FDA Product Code

• LKF: Cannula, Manipulator/Injector, Uterine

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-06

On-Brand Devices [ABBI]

• 60888937014183: ABBI™ KIT (Air Bubble Based Infuser) For office based Sono HSG Procedures
• 00888937014174: ABBI™ (Air Bubble Based Infuser) For office based Sono HSG Procedures