Protekt Regulator

Basic Information

• Brand Name: Protekt Regulator
• Primary DI: 05060488573156
• Version / Model: PMREG015BM
• Catalog Number: PMREG015BM
• Company Name: PROACTIVE MEDICAL PRODUCTS, LLC
• Labeler DUNS: 078582655
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-13
• Public Version: 2
• Public Version Date: 2022-10-25
• Public Version Status: Update
• Public Device Record Key: dabb2d02-41a4-4c38-b509-8de6beb98d03

Device Description

Oxygen Regulator, 0-15 LPM Mini Size, CGA 870, Barb Outlet

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: Yes
• Has Serial Number: Yes
• 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
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	868.2700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44472	Oxygen therapy conserving regulator	A device that is connected to an independent supply of oxygen (O2), typically an oxygen gas cylinder, and is used to regulate the high pressure of the supply to a safe working pressure which is delivered to the patient requiring oxygen therapy and ensuring that the prescribed (set/dialed) dosage of O2 is maintained at an accurate level. It acts both as a pressure reduction device and an O2 saving device. Commonly known as an oxygen conserving regulator it may be designed to provide a bolus of O2 to the patient by metering the gas over the normal inspiration/expiration phases, thus conserving it.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060488573156	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	6	Inch
Width	2	Inch
Height	2	Inch