FERNO2 OX Inhalator

Basic Information

• Brand Name: FERNO2 OX Inhalator
• Primary DI: 00814940020208
• Version / Model: T25302-10
• Catalog Number: T25302-10
• Company Name: Spiracle Technology
• Labeler DUNS: 836002451
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-09
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 30bc1276-8000-48ae-b004-50b0e888857d

Device Description

OX Series Inhalator valve, demand valve used with spontaneously breathing patients

Device Characteristics

• Single Use: No
• 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: No
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CBP	Valve, Non-Rebreathing	Anesthesiology	868.5870	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17169	Demand valve	A non-sterile device that is used to regulate the therapeutic gas flow to a patient in response to the patient's breathing effort. It is used, e.g., in ventilator breathing circuits, resuscitation devices and in on demand analgesia devices. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00814940020208	GS1

Premarket Submissions

Submission Number	Supplement Number
K963755	000