Disposable Silicone Foley Catheter Two-way 24Fr

GUDID 26938634494880

Guangdong Baihe Medical Technology Co., Ltd.

Indwelling urethral drainage catheter

• Primary Device ID: 26938634494880
• NIH Device Record Key: b4051fa3-3e87-4e2c-9094-9d0f180f50b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Silicone Foley Catheter Two-way 24Fr
• Version Model Number: 110-FX-022440
• 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	06938634494886 [Primary]
GS1	16938634494883 [Package]; Contains: 06938634494886; Package: [10 Units]; In Commercial Distribution
GS1	26938634494880 [Package]; Contains: 16938634494883; 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 24Fr]

• 26938634494880: 110-FX-022440
• 26938634494873: 040-FX-022440