Disposable Hemodialysis Access Catheter Set FR-2615

GUDID 26938634471454

Guangdong Baihe Medical Technology Co., Ltd.

Haemodialysis catheterization kit

• Primary Device ID: 26938634471454
• NIH Device Record Key: 884d1ef9-b2c5-44c7-b8e2-80b25ac47fb9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Hemodialysis Access Catheter Set
• Version Model Number: Double Lumen6.5F*16cm
• Catalog Number: FR-2615
• 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	06938634471450 [Primary]
GS1	16938634471457 [Package]; Contains: 06938634471450; Package: [10 Units]; In Commercial Distribution
GS1	26938634471454 [Package]; Contains: 16938634471457; 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