Easy Pulse 5 Oxygen Conserving Regulator

Basic Information

• Brand Name: Easy Pulse 5 Oxygen Conserving Regulator
• Primary DI: 00855887006979
• Version / Model: 198705-RM
• Company Name: Precision Medical, Inc.
• Labeler DUNS: 112569116
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-22
• Public Version: 3
• Public Version Date: 2023-08-17
• Public Version Status: Update
• Public Device Record Key: 5b662d92-cb4b-454e-8346-3e9fcfcf877d

Device Description

1900 SERIES,REG,02,EP5,870,GAUGE,12POS, NON-CE

Device Characteristics

• Single Use: No
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
CAW	Generator, Oxygen, Portable	Anesthesiology	868.5440	2

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	00855887006979	GS1