Silicone Supra-Pubic Catheter (Integrated Balloon)

GUDID 04710961937555

FORTUNE MEDICAL INSTRUMENT CORP.

Suprapubic drainage catheter

• Primary Device ID: 04710961937555
• NIH Device Record Key: 2656e076-4ebb-4865-a3d4-0efa21e5a19b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone Supra-Pubic Catheter (Integrated Balloon)
• Version Model Number: 4890-0214
• 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	04710961937555 [Primary]
GS1	14710961937552 [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 (Integrated Balloon)]

• 04710961937609: 4890-0224
• 04710961937593: 4890-0222
• 04710961937586: 4890-0220
• 04710961937579: 4890-0218
• 04710961937562: 4890-0216
• 04710961937555: 4890-0214
• 04710961937548: 4890-0212
• 04710961937531: 4890-0210