Silicone 3-way Foley Balloon Catheter (Standard Ba

GUDID 04710961932543

FORTUNE MEDICAL INSTRUMENT CORP.

Indwelling urethral drainage catheter

• Primary Device ID: 04710961932543
• NIH Device Record Key: 031cf566-d988-4993-b4e6-bcc7f71be36f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone 3-way Foley Balloon Catheter (Standard Ba
• Version Model Number: 1830-0518
• Company DUNS: 656763489
• Company Name: FORTUNE MEDICAL INSTRUMENT CORP.
• Device Count: 10
• 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	04710961932543 [Primary]
GS1	14710961932540 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980919

FDA Product Code

• EZL: Catheter, Retention Type, Balloon

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2018-09-24
• Device Publish Date: 2016-03-11

On-Brand Devices [Silicone 3-way Foley Balloon Catheter (Standard Ba]

• 04710961932581: 1830-0526
• 04710961932574: 1830-0524
• 04710961932567: 1830-0522
• 04710961932550: 1830-0520
• 04710961932543: 1830-0518
• 04710961932536: 1830-0516
• 04710961932529: 1830-0514