TEMPERATURE SENSING FOLEY BALLOON CATHETER

GUDID 08806369403801

Temperature Sensing/Blue 5cc 18fr

Sewoon Medical Co., Ltd.

Temperature-monitoring indwelling urethral drainage catheter

• Primary Device ID: 08806369403801
• NIH Device Record Key: d5a35aaf-5469-475d-85c8-44c91c82c6e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TEMPERATURE SENSING FOLEY BALLOON CATHETER
• Version Model Number: 2105-018
• Company DUNS: 687784405
• Company Name: Sewoon Medical Co., Ltd.
• Device Count: 1
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806369403801 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022287

FDA Product Code

• EZL: Catheter, Retention Type, Balloon

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-01
• Device Publish Date: 2023-07-24

On-Brand Devices [TEMPERATURE SENSING FOLEY BALLOON CATHETER]

• 08806369403801: Temperature Sensing/Blue 5cc 18fr
• 08806369403788: Temperature Sensing/Blue 5cc 16fr
• 08806369403764: Temperature Sensing/Blue 5cc 14fr
• 08806369403740: Temperature Sensing/Blue 5cc 12fr
• 08806369403726: Temperature Sensing/Blue 3cc 10fr
• 08806369403702: Temperature Sensing/Blue 3cc 8fr