Disposable Anesthesia Circuit

Basic Information

• Brand Name: Disposable Anesthesia Circuit
• Primary DI: 00709078008252
• Version / Model: 9678
• Company Name: WESTMED, INC.
• Labeler DUNS: 092673953
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-31
• Public Version: 6
• Public Version Date: 2023-08-11
• Public Version Status: Update
• Public Device Record Key: 6df39160-bef7-4fcb-a9a3-ced1affb9fd7
• Distribution End Date: 2023-08-11

Device Description

Adult Circuit, 72" Expandable Circuit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: No
• 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
OFP	Anesthesia Breathing Circuit Kit (Adult & Pediatric)	Anesthesiology	868.5240	1
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	868.5260	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37704	Anaesthesia breathing circuit, single-use	An assembly of devices designed to conduct medical gases from an anaesthesia unit/workstation to a patient artificial airway/anaesthesia mask (not included) during general anaesthesia. It includes breathing tubes and a Y-piece connector, typically with a ventilator/ventilation bag and appropriate connectors, and may include a carbon dioxide (CO2) absorber, a one-way directional valve, or adjustable pressure limiting (APL) valve. This is a single-use device.	No	Active
46816	Heat/moisture exchanger/microbial medical gas filter	A device intended to be placed within a breathing circuit proximal to the patient, to remove and retain microbes whilst capturing the patient's exhaled heat and moisture so that they can be used to heat and humidify the therapeutic gases inspired by the patient. It is typically a plastic housing which contains both a bidirectional microbial filter, intended to reduce the risk of cross-contamination between patients, and a heat/moisture exchanger (HME), intended to maintain the mucous membranes of the respiratory tract. It is typically used during anaesthesia or periods of prolonged respiratory support/therapy. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10709078008259	GS1		20	Not in Commercial Distribution	2023-08-11
Primary	00709078008252	GS1