ECO HME

Basic Information

• Brand Name: ECO HME
• Primary DI: 15060120952650
• Version / Model: 9080/750 Resmed 27922 Rev01
• Company Name: GVS Technology (Suzhou) Co., Ltd.
• Labeler DUNS: 420798347
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: c47c9ea2-bb3f-482a-888d-6316dcb0b2c4

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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
Primary	15060120952650	GS1
Unit of Use	15060120952653	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -5 – 40 Degrees Celsius