SafetyO2

Basic Information

• Brand Name: SafetyO2
• Primary DI: 00817494020700
• Version / Model: AM-OXY-FP
• Company Name: GROMAN INC.
• Labeler DUNS: 020124663
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-01
• Public Version: 1
• Public Version Date: 2023-03-09
• Public Version Status: New
• Public Device Record Key: d34cc33d-605b-4d3d-9cb5-253dc0a3e91e
• Distribution End Date: 2123-03-01

Device Description

One SafetyO2 Kit Non-rebreather Oxygen Mask with FacePlate and Tubing

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	868.5570	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35173	Non-rebreathing oxygen face mask	A non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver air of high oxygen (O2) concentration to a patient's airway. It typically includes two unidirectional valves, one that closes during inspiration to prevent room air mixing with oxygen in a reservoir bag, and one that closes during exhalation to prevent exhaled respiratory gases from entering the reservoir bag. It is made of soft, flexible polymers designed to create an airtight seal against the patient's face. It may include tubing, and various valves and connectors, however other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10817494020707	GS1	Box	25	In Commercial Distribution	2123-03-01
Primary	00817494020700	GS1
Package	20817494020704	GS1	Box	50	In Commercial Distribution	2123-03-01
Package	30817494020701	GS1	Box	100	In Commercial Distribution	2123-03-01