Disposable Silicone Foley Catheter Two-way 20Fr

GUDID 26938634494859

Guangdong Baihe Medical Technology Co., Ltd.

Indwelling urethral drainage catheter

• Primary Device ID: 26938634494859
• NIH Device Record Key: 37a9e2cc-93c9-441f-aca7-d183ab2f19e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Silicone Foley Catheter Two-way 20Fr
• Version Model Number: 110-FX-022040
• 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	06938634494855 [Primary]
GS1	16938634494852 [Package]; Contains: 06938634494855; Package: [10 Units]; In Commercial Distribution
GS1	26938634494859 [Package]; Contains: 16938634494852; 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 20Fr]

• 26938634494859: 110-FX-022040
• 26938634494842: 040-FX-022040