KM 030 Disposable Connector with LCD Thermometer

Basic Information

• Brand Name: KM 030 Disposable Connector with LCD Thermometer
• Primary DI: M996KM0300
• Version / Model: KM 030
• Catalog Number: KM 030
• Company Name: INSTRUMENTATION INDUSTRIES, INCORPORATED
• Labeler DUNS: 053146767
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-31
• Public Version: 6
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: 2eb9692d-1fbf-4b2a-9565-ac5522b586e0

Device Description

The KM 030 Disposable Connector with LCD Thermometer is intended for use in a ventilator circuit, or a heated aerosol circuit. The LCD thermometer gives approximate temperature readings only and is not a substitute for definitive temperature monitoring. Dimensions: 22mm O.D. x 22mm I.D. Single Patient Use. Molded of High Density Polyethylene.

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: High-level Disinfectant, Moist Heat or Steam Sterilization

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
61346	Straight/elbow breathing circuit connector, single-use	A device intended to create a direct connection between a breathing circuit breathing tube and an endotracheal (ET) tube, anaesthesia face mask, or other non-sampling breathing circuit component. It is constructed with specific connecting dimensions and may be designed to connect breathing tubes from paediatric to adult sizes. It is typically made of plastic materials and can have a straight or elbow-shaped design (excludes Y-piece connectors). Some designs may allow for partial rotation at the point of connection (a swivel) and may include a suction port or gas sampling port. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M996KM0305	HIBCC	Ziplock bag	50	In Commercial Distribution
Primary	M996KM0300	HIBCC

Customer Contacts

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