Silicone 2-way Foley Catheter Tiemann Tip (Standar

GUDID 04710961933373

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: 04710961933373
• NIH Device Record Key: 8a4e2e58-b4fc-4347-8173-a9d83c7a058c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone 2-way Foley Catheter Tiemann Tip (Standar
• Version Model Number: 1856-0218
• 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: false
• 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	04710961933373 [Primary]
GS1	14710961933370 [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 Catheter Tiemann Tip (Standar]

• 04710961933403: 1856-0224
• 04710961933397: 1856-0222
• 04710961933380: 1856-0220
• 04710961933373: 1856-0218
• 04710961933366: 1856-0216
• 04710961933359: 1856-0214
• 04710961933342: 1856-0212
• 04710961933335: 1856-0210