AQUESURE FILTER HUMIDIFIER

Basic Information

• Brand Name: AQUESURE FILTER HUMIDIFIER
• Primary DI: 10629160012608
• Version / Model: OL-040419-U00
• Catalog Number: OL-040419-U00
• Company Name: BOMImed Inc
• Labeler DUNS: 248200149
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-26
• Public Version: 5
• Public Version Date: 2021-12-22
• Public Version Status: Update
• Public Device Record Key: b4d71bda-ca8e-4265-9b25-9834a7f581f7

Device Description

Breathing circuit filter with built-in humidification

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
46816	Heat/moisture exchanger/microbial medical gas filter	A device intended to be placed within a breathing circuit proximal to the patient, to remove and retain microbes whilst capturing the patient's exhaled heat and moisture so that they can be used to heat and humidify the therapeutic gases inspired by the patient. It is typically a plastic housing which contains both a bidirectional microbial filter, intended to reduce the risk of cross-contamination between patients, and a heat/moisture exchanger (HME), intended to maintain the mucous membranes of the respiratory tract. It is typically used during anaesthesia or periods of prolonged respiratory support/therapy. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20629160012605	GS1	box	50	In Commercial Distribution
Primary	10629160012608	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K033008	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Cool dry area away from direct light