ABLE CENTRAL VENOUS CATHETER FV-3523

GUDID 26938634479412

Guangdong Baihe Medical Technology Co., Ltd.

Central venous catheterization kit, short-term

• Primary Device ID: 26938634479412
• NIH Device Record Key: bcb76bd7-0298-4cd6-b129-e5af4bd038f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ABLE CENTRAL VENOUS CATHETER
• Version Model Number: Triple Lumen 5.5F*10cm
• Catalog Number: FV-3523
• 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	06938634479418 [Primary]
GS1	16938634479415 [Package]; Contains: 06938634479418; Package: [10 Units]; In Commercial Distribution
GS1	26938634479412 [Package]; Contains: 16938634479415; 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]

• 26938634479900: Triple Lumen 7F*16cm
• 26938634479849: Triple Lumen 7F*15cm
• 26938634479696: Triple Lumen 5.5F*20cm
• 26938634479627: Triple Lumen 5.5F*16cm
• 06938634479579: Triple Lumen 5.5F*15cm
• 26938634479511: Triple Lumen 5.5F*13cm
• 26938634479412: Triple Lumen 5.5F*10cm
• 26938634479337: Triple Lumen 5.5F*8cm
• 26938634479214: Triple Lumen 5.5F*5cm
• 26938634478682: Double Lumen 8F*20cm
• 26938634478651: Double Lumen 8F*16cm
• 26938634478576: Double Lumen 8F*13cm
• 26938634478545: Double Lumen 8F*10cm
• 26938634478361: Double Lumen 7F*45cm
• 26938634478286: Double Lumen 7F*25cm
• 26938634478194: Double Lumen 7F*20cm
• 26938634478088: Double Lumen 7F*16cm
• 26938634478026: Double Lumen 7F*15cm
• 26938634477838: Double Lumen 5F*20cm
• 26938634477760: Double Lumen 5F*16cm
• 06938634477698: Double Lumen 5F*15cm
• 26938634477609: Double Lumen 5F*13cm
• 26938634477432: Double Lumen 5F*8cm
• 26938634477302: Double Lumen 5F*5cm
• 26938634477203: Double Lumen 4F*16cm
• 26938634477074: Double Lumen 4F*13cm
• 26938634476985: Double Lumen 4F*10cm
• 26938634476886: Double Lumen 4F*8cm
• 26938634476756: Double Lumen 4F*5cm
• 26938634476367: Single Lumen 20G*30cm
• 26938634476336: Single Lumen 20G*20cm
• 26938634476305: Single Lumen 20G*16cm
• 26938634476206: Single Lumen 20G*13cm
• 26938634476145: Single Lumen 20G*10cm
• 26938634476091: Single Lumen 20G*8cm
• 26938634476046: Single Lumen 20G*5cm
• 26938634475940: Single Lumen 18G*20cm
• 26938634475889: Single Lumen 18G*16cm
• 26938634475841: Single Lumen 18G*15cm
• 26938634475759: Single Lumen 18G*10cm
• 26938634475780: Single Lumen 18G*13cm
• 26938634475735: Single Lumen 18G*8cm
• 26938634475599: Single Lumen 16G*30cm
• 26938634475568: Single Lumen 16G*25cm
• 26938634475513: Single Lumen 16G*20cm
• 26938634475483: Single Lumen 16G*16cm
• 26938634475452: Single Lumen 16G*15cm
• 26938634475315: Single Lumen 14G*30cm
• 26938634475292: Single Lumen 14G*25cm
• 26938634475247: Single Lumen 14G*20cm