Able Central Venous Catheter Double Lumen 8F*30cm FV-2828

GUDID 26938634478750

Guangdong Baihe Medical Technology Co., Ltd.

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• Primary Device ID: 26938634478750
• NIH Device Record Key: 03f4633d-8a20-4d10-bafd-89538efb2e0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Able Central Venous Catheter Double Lumen 8F*30cm
• Version Model Number: Double Lumen 8F*30cm
• Catalog Number: FV-2828
• 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	06938634478756 [Primary]
GS1	16938634478753 [Package]; Contains: 06938634478756; Package: [10 Units]; In Commercial Distribution
GS1	26938634478750 [Package]; Contains: 16938634478753; Package: [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070451

FDA Product Code

• FOZ: Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

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: 2024-06-17
• Device Publish Date: 2016-09-22

On-Brand Devices [Able Central Venous Catheter Double Lumen 8F*30cm]

• 26938634490288: 01L-FV-2828
• 26938634478750: Double Lumen 8F*30cm