Critikit™ 680006/A

GUDID 20884450320932

ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.

Invasive blood pressure monitoring tubing set

• Primary Device ID: 20884450320932
• NIH Device Record Key: d9337753-abcb-4ebd-a9f1-3972386dee1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Critikit™
• Version Model Number: 10884450320935
• Catalog Number: 680006/A
• Company DUNS: 595138793
• Company Name: ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
• Device Count: 25
• 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	00884450320938 [Unit of Use]
GS1	10884450320935 [Primary]
GS1	20884450320932 [Package]; Contains: 10884450320935; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• DQO: CATHETER, INTRAVASCULAR, DIAGNOSTIC

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: 2021-12-13
• Device Publish Date: 2018-01-31

On-Brand Devices [Critikit™]

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