HeliO2 Blender

Basic Information

• Brand Name: HeliO2 Blender
• Primary DI: 00855887006047
• Version / Model: PM5470
• Company Name: Precision Medical, Inc.
• Labeler DUNS: 112569116
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-12-17
• Public Version: 5
• Public Version Date: 2023-08-18
• Public Version Status: Update
• Public Device Record Key: 2f115024-ad21-49ca-a69d-81524f69226f

Device Description

PM5400 SERIES,BLENDER,HE/O2,LOW FLOW,70/30

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
BZR	Mixer, Breathing Gases, Anesthesia Inhalation	Anesthesiology	868.5330	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58317	Helium/oxygen breathing gas mixer	An independent mechanical device designed for accurate mixing of helium (He) and oxygen (O2) with concentrations ranging from 80% He and 20% O2, or 70% He and 30% O2 (helium/oxygen proportioner) that are appropriated for breathing in a patient who is indicated to assist flow of O2 into the alveoli and to reduce the work of breathing, e.g., severe airway obstruction. The mixer receives oxygen and helium from either the hospital gas pipeline and/or from compressed gas cylinders; it may include a pressure-regulating mechanism. The mixer may deliver the gas to the patient through devices such as ventilators, tracheostomy tubes, endotracheal (ET) tubes, and/or masks.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00855887006047	GS1

Premarket Submissions

Submission Number	Supplement Number
K090781	000