HG 100 Humidifier Guard

Basic Information

• Brand Name: HG 100 Humidifier Guard
• Primary DI: M996HG1000
• Version / Model: HG 100
• Catalog Number: HG 100
• Company Name: INSTRUMENTATION INDUSTRIES, INCORPORATED
• Labeler DUNS: 053146767
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-15
• Public Version: 1
• Public Version Date: 2022-11-23
• Public Version Status: New
• Public Device Record Key: 5a6b5bf5-f5ab-4ef2-89e3-dfc1ff1fd2f8

Device Description

The HG 100 Humidifier Guard is intended for use with a humidifier installed within a ventilator circuit. The device allows for safe removal of condensation and patient secretions that have accumulated in the inspiratory limb of a ventilator circuit. The HG100 protects the humidifier by allowing these liquids to be collected in the device and then to be easily removed by suction when necessary.

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: MR Unsafe
• 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: Hydrogen Peroxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BYH	Drain, Tee (Water Trap)	Anesthesiology	868.5995	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31286	Breathing circuit condensate trap, reusable	A non-sterile device intended to be integrated within a breathing circuit (e.g., ventilator breathing circuit) to collect the condensate which accumulates typically during heated humidification. It includes a fluid collection container with input and output connections, and may have an automatic seal to prevent the leak of fluid when removed from the circuit; it does not include a moisture filter. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M996HG1001	HIBCC	Zip-lock bag	5	In Commercial Distribution
Primary	M996HG1000	HIBCC
Package	M996HG1002	HIBCC	Zip-lock bag	10	In Commercial Distribution

Customer Contacts

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