RespVent™

Basic Information

• Brand Name: RespVent™
• Primary DI: 00850108006080
• Version / Model: RTG-01052
• Catalog Number: RTG-01052
• Company Name: CUTTING EDGE HC BRANDS LLC
• Labeler DUNS: 080216804
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-30
• Public Version: 1
• Public Version Date: 2023-01-09
• Public Version Status: New
• Public Device Record Key: 83509f41-bae0-4bd2-8fdf-d27581487c84

Device Description

RespVent Tracheostomy T- HME with Front Oxygen Port is a single use heat and moisture exchanger which transfers heat and humidity from the gas expired by the patient to the inspired gases. RespVent Trach T-HME is intended for use on patients who are breathing spontaneously through a tracheostomy tube.

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: 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	868.5375	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35530	Heat/moisture exchanger, single-use	A one-piece, canister-like device that connects in-line with a patient's artificial airway [e.g., an endotracheal (ET) tube], to capture the patient's exhaled heat and moisture so that they can be used to heat and humidify therapeutic gases inspired by the patient; it does not include a microbial filter. Commonly known as a heat & moisture exchanger (HME) or an "artificial nose", it is used when the patient is subjected to extended periods of breathing dry gases such as during anaesthesia or intensive care ventilation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850108006087	GS1	Carton	50	In Commercial Distribution
Primary	00850108006080	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Connector-patient side: 15 F