FDA.reportPublic FDA data

Easy Pulse II Oxygen Conserver

Primary DI
00855887006948
Brand
Easy Pulse II Oxygen Conserver
Company
Precision Medical, Inc.
Model
198705OG
Device description
1900 SERIES,REG,02,EP5,870,GAUGE,OG
Published
2020-09-29
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
CAWGenerator, Oxygen, Portable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAWGenerator, Oxygen, PortableAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032018000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032018000EASY PULSE II OXYGEN CONSERVERPrecision Medical, Inc.2003-08-25NFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855887006948PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855887006948008558870069488558870069480855887006948

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen therapy conserving regulatorA 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.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810178889624Vive BreatheVIVE HEALTH LLCCAW2026-06-01
00885304034834DeVilbissDEVILBISS HEALTHCARE LLCCAW2026-05-12
00885304034841DeVilbissDEVILBISS HEALTHCARE LLCCAW2026-05-12
00885304034858DeVilbissDEVILBISS HEALTHCARE LLCCAW2026-05-12
00860007698262MOSTPacific Consolidated Industries LLCCAW2026-05-06
06934726614316LongfianLongfian Scitech Co., Ltd.CAW2026-05-04
00810178885756ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885763ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885770ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885787ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885794ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885800ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885817ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885824ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00850083102944Rhythm Healthcare, LLCRhythm Healthcare, LLCCAW2026-04-24
00850083102319Rhythm HealthcareRhythm Healthcare, LLCCAW2026-04-22
15060031380191RUGGED OXYGEN GENERATOR (ROG)MOLECULAR PRODUCTS LIMITEDCAW2026-04-21
06933257948488YUWELL Portable Oxygen ConcentratorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.CAW2026-02-24
00810178884452ViveBreatheVIVE HEALTH LLCCAW2026-01-30
00850018761451Internal Battery PM Upgrade USB DriveVentec Life Systems, Inc.CAW2025-12-02
M766AS200SW460AryaCAIRE INC.CAW2025-08-13
00850018761413Internal Battery PM Upgrade USB DriveVentec Life Systems, Inc.CAW2025-08-06
06933257921856YUWELL Oxygen ConcentratorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.CAW2024-01-09
10840330700396ProcureTwin Med, LLCCAW2022-11-03
M766AS200SW6AryaCAIRE INC.CAW2022-05-26
00855573007761VOCSNVentec Life Systems, Inc.CAW2022-04-12
00709078014062InLine Water TrapWESTMED, INC.CAW2022-03-31
00850018761178VOCSN Power SupplyVentec Life Systems, Inc.CAW2022-03-23
00850018761130VOCSNVentec Life Systems, Inc.CAW2021-03-03
00850018761048VOCSN Patient Breathing PackageVentec Life Systems, Inc.CAW2020-10-07