FDA.reportPublic FDA data

Precision Medical

Primary DI
00850027043746
Brand
Precision Medical
Company
Precision Medical, Inc.
Model
19HF05
Catalog number
19HF05
Device description
1900 SERIES,REG,O2,EP5,HOMEFILL,NON-CE
Published
2024-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NFBConserver, Oxygen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFBConserver, OxygenAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850027043746PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850027043746008500270437468500270437460850027043746

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
6102626090info@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
10889483599556AirLife™AIRLIFENFB2025-02-19
10889483605783AirLife™AIRLIFENFB2025-02-19
30889483599550AirLife™Sunmed Group Holdings, LLCNFB2025-02-19
30889483605787AirLife™Sunmed Group Holdings, LLCNFB2025-02-19
10889483605806AirLife™AIRLIFENFB2025-02-18
30889483605800AirLife™Sunmed Group Holdings, LLCNFB2025-02-18
00822383024875SmartDose EvolutionINOVO, INC.NFB2024-11-07
50822383024870SmartDose EvolutionINOVO, INC.NFB2024-11-07
00850027997001DynarisIncoba LLCNFB2023-12-14
00822383504322DriveINOVO, INC.NFB2023-10-16
00822383018553EVOLUTION INOVO, INC.NFB2023-05-25
00822383515557Evolution™INOVO, INC.NFB2023-05-25
50822383018558EVOLUTION INOVO, INC.NFB2023-05-25
50822383515552Evolution™INOVO, INC.NFB2023-05-25
00822383018522EVOLUTION INOVO, INC.NFB2023-04-28
00822383018515DriveINOVO, INC.NFB2022-09-21
00814470020297BONSAI INOVO, INC.NFB2021-09-20
10080196193080MedlineMEDLINE INDUSTRIES, INC.NFB2021-03-31
10080196752287MedlineMEDLINE INDUSTRIES, INC.NFB2021-03-31
10190752115057Airlife™AIRLIFENFB2021-03-09
50190752115055Airlife™VYAIRE MEDICAL, INC.NFB2021-03-09
00855887006962Easy Pulse 5 Oxygen Conserving RegulatorPrecision Medical, Inc.NFB2021-03-05
00855887006627Easy Pulse 5 Oxygen Conserving RegulatorPrecision Medical, Inc.NFB2021-02-25
00854485007197ARES Nasal CannulaWatermark Medical, Inc.NFB2021-02-22
00822383274485driveDrive Devilbiss HealthcareNFB2020-07-01
00822383283814driveDrive Devilbiss HealthcareNFB2020-07-01
00822383284101driveDrive Devilbiss HealthcareNFB2020-07-01
00822383296401driveDrive Devilbiss HealthcareNFB2020-07-01
00885304002970DeVilbissDrive Devilbiss HealthcareNFB2020-04-03
00885304007197DeVilbissDrive Devilbiss HealthcareNFB2020-02-11