Silicone Supra-Pubic Catheter (Ordinary Balloon)

GUDID 04710961933472

FORTUNE MEDICAL INSTRUMENT CORP.

Suprapubic drainage catheter

• Primary Device ID: 04710961933472
• NIH Device Record Key: f189c12b-53cd-4c13-8df9-5500f49fda88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone Supra-Pubic Catheter (Ordinary Balloon)
• Version Model Number: 1857-0212
• 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	04710961933472 [Primary]
GS1	14710961933479 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K014002

FDA Product Code

• KOB: Catheter, Suprapubic (And Accessories)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-03-15

On-Brand Devices [Silicone Supra-Pubic Catheter (Ordinary Balloon)]

• 04711182606978: 1857-0214
• 04711182606961: 1857-0216
• 04710961934189: 1890-0224
• 04710961934172: 1890-0222
• 04710961934165: 1890-0220
• 04710961934158: 1890-0218
• 04710961934141: 1890-0216
• 04710961934134: 1890-0214
• 04710961934127: 1890-0212
• 04710961933472: 1857-0212