ENDURE INDUSTRIES

Basic Information

• Brand Name: ENDURE INDUSTRIES
• Primary DI: 00840118613507
• Version / Model: FH17
• Catalog Number: FH17
• Company Name: ENDURE INDUSTRIES
• Labeler DUNS: 066087031
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-10
• Public Version: 1
• Public Version Date: 2024-04-18
• Public Version Status: New
• Public Device Record Key: 97b17136-1a62-4520-b873-8d58b950e2d0

Device Description

HMEF Filter

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	868.5260	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37597	Heat/moisture exchanger insertable filter	A dedicated membrane that is inserted into a reusable heat & moisture exchanger (HME) to capture a patient's exhaled heat and moisture, so that they can be used to heat and humidify therapeutic gases inspired by the patient typically 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	00840118613941	GS1	Case	50	In Commercial Distribution
Primary	00840118613507	GS1
Package	00840118605939	GS1	Case	500	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K132709	000