Silicone 2-way Foley Balloon Catheter (Grooved Bal

GUDID 04711182628574

FORTUNE MEDICAL INSTRUMENT CORP.

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• Primary Device ID: 04711182628574
• NIH Device Record Key: 04f75e1e-7728-4d81-8621-7f96899533f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone 2-way Foley Balloon Catheter (Grooved Bal
• Version Model Number: 1827-0016
• 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	04711182628574 [Primary]
GS1	14711182628571 [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: 2016-03-14

On-Brand Devices [Silicone 2-way Foley Balloon Catheter (Grooved Bal]

• 04711182628598: 1827-0012
• 04711182628581: 1827-0014
• 04711182628574: 1827-0016
• 04711182628567: 1827-0018
• 04711182628550: 1827-0020
• 04711182628543: 1827-0022
• 04711182628536: 1827-0024