Able Central Venous Catheter Double Lumen 7F*30cm

GUDID 26938634492015

Guangdong Baihe Medical Technology Co., Ltd.

Central venous catheter Centrally-inserted central venous catheter Centrally-inserted central venous catheter Centrally-inserted central venous catheter Centrally-inserted central venous catheter Centrally-inserted central venous catheter Centrally-inserted central venous catheter Centrally-inserted central venous catheter Centrally-inserted central venous catheter Centrally-inserted central venous catheter Centrally-inserted central venous catheter Centrally-inserted central venous catheter Centrally-inserted central venous catheter Centrally-inserted central venous catheter Centrally-inserted central venous catheter Centrally-inserted central venous catheter Centrally-inserted central venous catheter

• Primary Device ID: 26938634492015
• NIH Device Record Key: 2b5f75d5-a5d7-4f5e-8d52-b38ab60ddb71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Able Central Venous Catheter Double Lumen 7F*30cm
• Version Model Number: 02Y-FV-2728
• 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: false
• 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	06938634492011 [Primary]
GS1	16938634492018 [Package]; Contains: 06938634492011; Package: [10 Units]; In Commercial Distribution
GS1	26938634492015 [Package]; Contains: 16938634492018; 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

On-Brand Devices [Able Central Venous Catheter Double Lumen 7F*30cm]

• 26938634492015: 02Y-FV-2728
• 26938634492008: 02L-FV-2728