Circuit

Basic Information

• Brand Name: Circuit
• Primary DI: 00619498219537
• Version / Model: 21953
• Catalog Number: 21953
• Company Name: RESMED PTY LTD
• Labeler DUNS: 751149311
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2017-05-09
• Public Version: 5
• Public Version Date: 2022-10-24
• Public Version Status: Update
• Public Device Record Key: 6bb1aaa1-d5e0-4b0d-abab-bb3b67c000f3

Device Description

Universal disposable circuit without filter

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	868.5240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37706	Ventilator breathing circuit, single-use	An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00619498219537	GS1
Unit of Use	10619498219534	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]