Critikit™ 689784/A

GUDID 20884450557109

ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.

Contrast medium injection system administration set

• Primary Device ID: 20884450557109
• NIH Device Record Key: 2a2effb7-47f2-4c70-b582-e3e12c48bed9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Critikit™
• Version Model Number: 10884450557102
• Catalog Number: 689784/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: 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450557105 [Unit of Use]
GS1	10884450557102 [Primary]
GS1	20884450557109 [Package]; Contains: 10884450557102; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K936182

FDA Product Code

• KRB: PROBE, THERMODILUTION

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: 2021-03-16
• Device Publish Date: 2021-03-08

On-Brand Devices [Critikit™]

• 20884450557109: 10884450557102
• 20884450320932: 10884450320935
• 20884450320918: 10884450320911
• 20884450320901: 10884450320904