Disposable Silicone Foley Catheter Two-way 16Fr

GUDID 26938634494798

Guangdong Baihe Medical Technology Co., Ltd.

Indwelling urethral drainage catheter

• Primary Device ID: 26938634494798
• NIH Device Record Key: 73bb26c0-195e-42ca-9457-32e61993871e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Silicone Foley Catheter Two-way 16Fr
• Version Model Number: 040-FX-021640
• Company DUNS: 547055364
• Company Name: Guangdong Baihe Medical Technology 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	06938634494794 [Primary]
GS1	16938634494791 [Package]; Contains: 06938634494794; Package: [10 Units]; In Commercial Distribution
GS1	26938634494798 [Package]; Contains: 16938634494791; Package: [200 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130908

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: 2016-09-20

On-Brand Devices [Disposable Silicone Foley Catheter Two-way 16Fr]

• 26938634494811: 110-FX-021640
• 26938634494804: 050-FX-021640
• 26938634494798: 040-FX-021640