Careflow™ 681699/A

GUDID 20884450321793

ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.

Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term Central venous catheterization kit, short-term

• Primary Device ID: 20884450321793
• NIH Device Record Key: 7338d82f-ae2c-40aa-97b9-9ea8b3e06596
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Careflow™
• Version Model Number: 10884450321796
• Catalog Number: 681699/A
• Company DUNS: 595138793
• Company Name: ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450321799 [Unit of Use]
GS1	10884450321796 [Primary]
GS1	20884450321793 [Package]; Contains: 10884450321796; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033500

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-01
• Device Publish Date: 2019-10-24

On-Brand Devices [Careflow™]

• 20884450321793: 10884450321796
• 20884450321809: 10884450321802
• 20884450357884: 10884450357887
• 20884450329096: 10884450329099
• 20884450321922: 10884450321925
• 20884450321908: 10884450321901
• 20884450321878: 10884450321871
• 20884450321816: 10884450321819
• 20884450321892: 10884450321895
• 20884450379244: 10884450379247
• 20884450321762: 10884450321765
• 20884450321595: 10884450321598
• 20884450321564: 10884450321567
• 20884450321885: 10884450321888
• 20884450321502: 10884450321505