22mm Smoothbore breathing system

Basic Information

• Brand Name: 22mm Smoothbore breathing system
• Primary DI: 00816472023108
• Version / Model: 51836000
• Company Name: Intersurgical Incorporated
• Labeler DUNS: 785952607
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-19
• Public Version: 1
• Public Version Date: 2023-06-27
• Public Version Status: New
• Public Device Record Key: ae5132cc-c600-4a59-aa53-edc1d88495f8

Device Description

22mm Smoothbore breathing system with monitoring line and exhalation valve, 1.6m

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: MR Safe
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CBP	Valve, Non-Rebreathing	Anesthesiology	868.5870	2

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	00816472023115	GS1		20	In Commercial Distribution
Primary	00816472023108	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K132143	000