SG 066 Oxygen Enrichment Kit

Basic Information

• Brand Name: SG 066 Oxygen Enrichment Kit
• Primary DI: M996SG0660
• Version / Model: SG 066
• Company Name: INSTRUMENTATION INDUSTRIES, INCORPORATED
• Labeler DUNS: 053146767
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-24
• Public Version: 6
• Public Version Date: 2021-09-16
• Public Version Status: Update
• Public Device Record Key: c921910c-46f2-47ac-893b-73c17001e2b3

Device Description

The SG 066 Oxygen Enrichment Kit is designed for use on certain ventilators to provide higher concentrations of oxygen to the patient by mixing room air with an oxygen source at the proximal airway.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Sterilization Methods: High-level Disinfectant

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	868.5895	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46867	Oxygen administration enhancement device	A non-sterile device intended to be used to rapidly provide a supply of inhaled oxygen (O2) at higher than normal concentrations (e.g., FiO2 concentrations of 70% at 6L/min), typically for a patient during recovery [e.g., in the operating room (OR)]. It typically includes tubing that connects directly to an O2 source, a reservoir bag that concentrates the O2 and enables confirmation of respiration through its movement, a coupling that connects into an artificial airway already in situ, and a port for exhalation of gases. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M996SG0660	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K992670	000