FDA.reportPublic FDA data

Easy Pulse 5 Oxygen Conserving Regulator

Primary DI
00855887006979
Brand
Easy Pulse 5 Oxygen Conserving Regulator
Company
Precision Medical, Inc.
Model
198705-RM
Device description
1900 SERIES,REG,02,EP5,870,GAUGE,12POS, NON-CE
Published
2021-04-22
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
00855887006979PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855887006979008558870069798558870069790855887006979

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

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Primary DI, Brand, Company table
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00860007698262MOSTPacific Consolidated Industries LLCCAW2026-05-06
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00850083102319Rhythm HealthcareRhythm Healthcare, LLCCAW2026-04-22
15060031380191RUGGED OXYGEN GENERATOR (ROG)MOLECULAR PRODUCTS LIMITEDCAW2026-04-21
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