Disposable Hemodialysis Access Catheter Set FR-2914

GUDID 26938634470976

Guangdong Baihe Medical Technology Co., Ltd.

Haemodialysis catheterization kit Haemodialysis catheterization kit Haemodialysis catheterization kit Haemodialysis catheterization kit Haemodialysis catheterization kit Haemodialysis catheterization kit Haemodialysis catheterization kit Haemodialysis catheterization kit Haemodialysis catheterization kit Haemodialysis catheterization kit Haemodialysis catheterization kit Haemodialysis catheterization kit Haemodialysis catheterization kit Haemodialysis catheterization kit Haemodialysis catheterization kit Haemodialysis catheterization kit Haemodialysis catheterization kit Haemodialysis catheterization kit Haemodialysis catheterization kit Haemodialysis catheterization kit Haemodialysis catheterization kit Haemodialysis catheterization kit Haemodialysis catheterization kit Haemodialysis catheterization kit Haemodialysis catheterization kit Haemodialysis catheterization kit Haemodialysis catheterization kit Haemodialysis catheterization kit Haemodialysis catheterization kit Haemodialysis catheterization kit Haemodialysis catheterization kit Haemodialysis catheterization kit Haemodialysis catheterization kit Haemodialysis catheterization kit

• Primary Device ID: 26938634470976
• NIH Device Record Key: 5886f92b-3cfc-49a4-805e-24fdc6a64096
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Hemodialysis Access Catheter Set
• Version Model Number: Double Lumen8.5F*13cm
• Catalog Number: FR-2914
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06938634470972 [Primary]
GS1	16938634470979 [Package]; Contains: 06938634470972; Package: [10 Units]; In Commercial Distribution
GS1	26938634470976 [Package]; Contains: 16938634470979; Package: [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102833

FDA Product Code

• MPB: Catheter, Hemodialysis, Non-Implanted

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-06-18
• Device Publish Date: 2016-09-22

On-Brand Devices [Disposable Hemodialysis Access Catheter Set ]

• 06938634469907: Double Lumen12F*16cm
• 06938634469822: Double Lumen12F*20cm
• 26938634472086: Single Lumen7F*13cm
• 26938634472048: Single Lumen7F*16cm
• 26938634472000: Single Lumen7F*20cm
• 26938634471966: Single Lumen8F*13cm
• 26938634471881: Single Lumen8F*16cm
• 26938634471843: Single Lumen8F*20cm
• 26938634471621: Double Lumen 6.5F*5cm
• 26938634471577: Double Lumen 6.5F*8cm
• 26938634471539: Double Lumen 6.5F*10cm
• 26938634471492: Double Lumen6.5F*13cm
• 26938634471454: Double Lumen6.5F*16cm
• 26938634471058: Double Lumen8.5F*8cm
• 26938634471010: Double Lumen8.5F*10cm
• 26938634470976: Double Lumen8.5F*13cm
• 26938634470938: Double Lumen8.5F*15cm
• 26938634470891: Double Lumen 8.5F*16cm
• 26938634470679: Double Lumen11.5F*13cm
• 26938634470662: Double Lumen11.5F*13cm
• 26938634470655: Double Lumen 11.5F*13cm
• 26938634470631: Double Lumen11.5F*15cm
• 26938634470617: Double Lumen11.5F*15cm
• 26938634470594: Double Lumen11.5F*16cm
• 26938634470587: Double Lumen11.5F*16cm
• 26938634470518: Double Lumen11.5F*20cm
• 26938634470495: Double Lumen 11.5F*20cm
• 26938634469987: Double Lumen12F*13cm
• 26938634469970: Double Lumen12F*13cm
• 26938634469932: Double Lumen12F*15cm
• 26938634469895: Double Lumen12F*16cm
• 26938634469819: Double Lumen12F*20cm
• 26938634469703: Double Lumen 14F*15cm
• 26938634469666: Double Lumen14F*16cm
• 26938634469628: Double Lumen 14F*20cm
• 26938634454426: Single Lumen7F*10cm
• 26938634454303: Single Lumen8F*10cm