Silicone 2-way Foley Balloon Catheter (Standard Ba

GUDID 04710961931874

FORTUNE MEDICAL INSTRUMENT CORP.

Indwelling urethral drainage catheter Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial

• Primary Device ID: 04710961931874
• NIH Device Record Key: 4f567a94-67f9-452c-b409-ea6b979a3646
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone 2-way Foley Balloon Catheter (Standard Ba
• Version Model Number: 1822-0512
• 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	04710961931874 [Primary]
GS1	14710961931871 [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 (Standard Ba]

• 04711182607081: 1821-0610
• 04711182607067: 1821-0608
• 04711182607050: 1821-0606
• 04710961932222: 1823-0526
• 04710961932215: 1823-0524
• 04710961932192: 1823-0520
• 04710961932185: 1823-0518
• 04710961932178: 1823-0516
• 04710961932161: 1823-0514
• 04710961931959: 1822-1012
• 04710961931942: 1822-0526
• 04710961931935: 1822-0524
• 04710961931928: 1822-0522
• 04710961931911: 1822-0520
• 04710961931904: 1822-0518
• 04710961931898: 1822-0516
• 04710961931881: 1822-0514
• 04710961931874: 1822-0512
• 04710961931720: 1821-0510
• 04710961931713: 1821-0508
• 04710961931706: 1821-0506