Critiflo™ 682060/A

GUDID 20884450323162

ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.

Invasive blood pressure monitoring flush tubing

• Primary Device ID: 20884450323162
• NIH Device Record Key: 1cdbc490-3649-4e03-bda9-3578bee6d6c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Critiflo™
• Version Model Number: 10884450323165
• Catalog Number: 682060/A
• Company DUNS: 595138793
• Company Name: ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
• Device Count: 10
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00884450323168 [Unit of Use]
GS1	10884450323165 [Primary]
GS1	20884450323162 [Package]; Contains: 10884450323165; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K791844

FDA Product Code

• KRA: Catheter, continuous flush

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: 2019-12-05
• Device Publish Date: 2019-11-27

On-Brand Devices [Critiflo™]

• 20884450323162: 10884450323165
• 20884450371859: 10884450371852
• 20884450323902: 10884450323905