Newport Medical

Basic Information

• Brand Name: Newport Medical
• Primary DI: 10884521540569
• Version / Model: BCD23811P
• Company Name: Newport Medical Instruments, Inc.
• Labeler DUNS: 050334275
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-20
• Public Version: 4
• Public Version Date: 2023-09-27
• Public Version Status: Update
• Public Device Record Key: 94f569ce-b3d5-4c69-adce-32e96381d921

Device Description

Pediatric (15 mm ID) J Ventilation Breathing 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: 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: No
• Has Expiration Date: Yes
• 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
37705	Ventilator breathing circuit, reusable	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, or other air-delivery therapeutic device such as a mechanical insufflator/exsufflator, to a patient. 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. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10884521644670	GS1	CASE	15	In Commercial Distribution
Primary	10884521540569	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Inside Diameter, 15, mm;

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in Cool Dry Place