Disposable Silicone Foley Catheter Two-way 12Fr

GUDID 26938634494774

Guangdong Baihe Medical Technology Co., Ltd.

Indwelling urethral drainage catheter Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial Indwelling urethral drainage balloon catheter, non-antimicrobial

• Primary Device ID: 26938634494774
• NIH Device Record Key: 4627448b-a11c-4058-965a-00e9e3c45509
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Silicone Foley Catheter Two-way 12Fr
• Version Model Number: 040-FX-021240
• 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	06938634494770 [Primary]
GS1	16938634494777 [Package]; Contains: 06938634494770; Package: [10 Units]; In Commercial Distribution
GS1	26938634494774 [Package]; Contains: 16938634494777; 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

Devices Manufactured by Guangdong Baihe Medical Technology Co., Ltd.

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• 26938634494750 - Disposable Silicone Foley Catheter Two-way 8Fr: 2018-09-24
• 26938634494767 - Disposable Silicone Foley Catheter Two-way 10Fr: 2018-09-24
• 26938634494774 - Disposable Silicone Foley Catheter Two-way 12Fr: 2018-09-24
• 26938634494774 - Disposable Silicone Foley Catheter Two-way 12Fr: 2018-09-24
• 26938634494781 - Disposable Silicone Foley Catheter Two-way 14Fr: 2018-09-24
• 26938634494798 - Disposable Silicone Foley Catheter Two-way 16Fr: 2018-09-24
• 26938634494804 - Disposable Silicone Foley Catheter Two-way 16Fr: 2018-09-24