FDA.reportPublic FDA data

HeliO2 Blender

Primary DI
00855887006054
Brand
HeliO2 Blender
Company
Precision Medical, Inc.
Model
PM5480
Device description
PM5400 SERIES,BLENDER,HE/O2,LOW FLOW,80/20
Published
2015-12-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZRMixer, Breathing Gases, Anesthesia Inhalation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZRMixer, Breathing Gases, Anesthesia InhalationAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090781000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090781000HELIO2 BLENDERPrecision Medical, Inc.2009-08-13BZR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855887006054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855887006054008558870060548558870060540855887006054

GMDN Terms#

Term, Definition table
TermDefinition
Helium/oxygen breathing gas mixerAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6102626090support@precisionmedical.com

Regulatory Flags#

DUNS number
112569116
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008500270431738MFA Flowmeters8MFA6000 SERIES2021-04-19
008500270431808MFA Flowmeters8MFA7000 SERIES2021-04-19
008558870067958MFA Flowmeters8MFA O2 Series2017-04-11
008558870068018MFA Flowmeters8MFA Air Series2017-04-11
00850027043791Precision MedicalPM11102026-02-25
00850027043807Precision MedicalPM11502026-02-25
00850027043821Precision Medical Inc.5026872026-02-25
00850027043838Precision Medical Inc.502687-122026-02-25
00850027043845Precision Medical Inc.PM10002026-02-25
00850027043852Precision Medical Inc.5044502026-02-25
00850027043814Precision MedicalPM36PCCM2026-01-05
00850027043777Precision Medical5MFA Series - O25MFA2025-10-07
00850027043784Precision Medical5MFA Series - Air5MFA2025-10-07
008500270434491MFA Flowmeters1MFA2001MOD2021-04-21
008500270431281MFA Flowmeters1MFA1001MOD2021-04-19
008500270431351MFA Flowmeters1MFA9001AM2021-04-19
008500270431421MFA FlowmetersY1MFAPCFP2021-04-19
008500270431591MFA Flowmeters1MFA6000 SERIES2021-04-19
008500270431661MFA Flowmeters1MFA7000 SERIES2021-04-19
008558870067401MFA Flowmeters1MFA O2 Series2017-04-11

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