GeniFlow

GUDID 00877972005155

GENICON, INC.

Surgical irrigation/aspiration tubing set

• Primary Device ID: 00877972005155
• NIH Device Record Key: 865aee81-3873-4c30-be1b-30745b65d04b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GeniFlow
• Version Model Number: 710-300-000
• Company DUNS: 079805400
• Company Name: GENICON, 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00877972005155 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041967

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-23
• Device Publish Date: 2017-05-05

On-Brand Devices [GeniFlow]

• 00877972005155: 710-300-000
• 00877972004752: 700-000-010
• 00877972004738: 700-105-010
• 00877972004653: 700-000-005
• 00877972002031: 710-305-033
• 00877972001935: 700-010-005
• 00877972001928: 700-005-010
• 00877972001911: 700-005-005