Able Central Venous Catheter Single Lumen 14G*25cm

GUDID 26938634490851

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: 26938634490851
• NIH Device Record Key: e1468ea1-53a1-4853-b652-c6dc7a516328
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Able Central Venous Catheter Single Lumen 14G*25cm
• Version Model Number: 02L-FV-1627
• 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	06938634490857 [Primary]
GS1	16938634490854 [Package]; Contains: 06938634490857; Package: [1 Units]; In Commercial Distribution
GS1	26938634490851 [Package]; Contains: 16938634490854; 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: 4
• Public Version Date: 2019-12-10
• Device Publish Date: 2016-09-20

On-Brand Devices [Able Central Venous Catheter Single Lumen 14G*25cm]

• 26983634490851: 02L-FV-1627
• 26938634490851: 02L-FV-1627