KC 012-5P 15mm ID Ventilator Tubing with Integral Cuffs

Basic Information

• Brand Name: KC 012-5P 15mm ID Ventilator Tubing with Integral Cuffs
• Primary DI: M996KC0125P0
• Version / Model: KC 012-5P
• Company Name: INSTRUMENTATION INDUSTRIES, INCORPORATED
• Labeler DUNS: 053146767
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-14
• Public Version: 4
• Public Version Date: 2022-10-24
• Public Version Status: Update
• Public Device Record Key: 10683b01-e50b-4d39-a336-73955f728dbe

Device Description

KC 012-5P - 12" length, 15mm ID, Clear Ventilator Tubing with Integral Cuffs. For Single Patient Use.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• 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: Yes
• Sterilization Methods: ["Radiation Sterilization", "Ethylene Oxide", "Liquid Chemical"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	868.5975	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	M996KC0125P0	HIBCC

Customer Contacts

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