Silicone 2-way Foley Balloon Catheter (Integrated

GUDID 04710961936527

FORTUNE MEDICAL INSTRUMENT CORP.

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• Primary Device ID: 04710961936527
• NIH Device Record Key: ef3a1e71-e5a3-441d-b439-dfc3510b82ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone 2-way Foley Balloon Catheter (Integrated
• Version Model Number: 4822-0514
• 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	04710961936527 [Primary]
GS1	14710961936524 [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 2-way Foley Balloon Catheter (Integrated ]

• 04710961936589: 4822-0526
• 04710961936572: 4822-0524
• 04710961936565: 4822-0522
• 04710961936558: 4822-0520
• 04710961936541: 4822-0518
• 04710961936534: 4822-0516
• 04710961936527: 4822-0514
• 04710961936510: 4822-0512