Critikit™

Basic Information

• Brand Name: Critikit™
• Primary DI: 10884450557102
• Version / Model: 10884450557102
• Catalog Number: 689784/A
• Company Name: ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
• Labeler DUNS: 595138793
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2021-03-08
• Public Version: 2
• Public Version Date: 2021-12-13
• Public Version Status: Update
• Public Device Record Key: 2a2effb7-47f2-4c70-b582-e3e12c48bed9

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KRB	PROBE, THERMODILUTION	Cardiovascular	870.1915	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47258	Contrast medium injection system administration set	A collection of noninvasive devices designed to conduct fluids between a contrast medium injection system and a patient catheter for the delivery of a contrast medium and/or saline solution to a patient undergoing a diagnostic imaging procedure. It consists of tubing with switches/valves and connectors to syringes/fluid/contrast medium injection system, and possibly a pressure transducer; it is typically made of plastic materials. This is a disposable device which may serve multiple patients before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884450557109	GS1		4	In Commercial Distribution
Primary	10884450557102	GS1
Unit of Use	00884450557105	GS1