ABBI

GUDID 00888937014174

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

Coopersurgical, Inc.

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