Rescuer O-Mask Oxygen Mask with Universal Tubing

Basic Information

• Brand Name: Rescuer O-Mask Oxygen Mask with Universal Tubing
• Primary DI: B0026210U0
• Version / Model: 6210-U
• Catalog Number: 6210-U
• Company Name: B.L.S. Systems Limited
• Labeler DUNS: 200103823
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-01
• Public Version: 1
• Public Version Date: 2021-04-09
• Public Version Status: New
• Public Device Record Key: e31022a4-09b2-4afe-8dd9-d86aed543b30

Device Description

Rescuer O-Mask Oxygen Mask with Universal Tubing (Child)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: 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	B0026210U7	HIBCC	Carton	50	In Commercial Distribution
Primary	B0026210U0	HIBCC
Package	B0026210U9	HIBCC	Carton	130	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Child