Disposable Silicone Foley Catheter FX-020831

GUDID 26938634484157

Guangdong Baihe Medical Technology Co., Ltd.

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• Primary Device ID: 26938634484157
• NIH Device Record Key: 7903ebb9-43f9-41c7-8169-9e0a57a12b71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Silicone Foley Catheter
• Version Model Number: Two-way 8Fr
• Catalog Number: FX-020831
• 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	06938634484153 [Primary]
GS1	16938634484150 [Package]; Contains: 06938634484153; Package: [10 Units]; In Commercial Distribution
GS1	26938634484157 [Package]; Contains: 16938634484150; Package: [20 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: 10
• Public Version Date: 2024-06-17
• Device Publish Date: 2016-09-20

On-Brand Devices [Disposable Silicone Foley Catheter]

• 26938634484225: Two-way 22Fr
• 26938634484157: Two-way 8Fr
• 26938634484140: Two-way 6Fr
• 26938634484164: Two-way 10Fr