FDA.reportPublic FDA data

Precision Medical Inc.

Primary DI
00855887006870
Brand
Precision Medical Inc.
Company
Precision Medical, Inc.
Model
PM5950
Catalog number
PM5950
Device description
Accu O2 Oxygen Analyzer
Published
2018-05-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCLAnalyzer, Gas, Oxygen, Gaseous-Phase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCLAnalyzer, Gas, Oxygen, Gaseous-PhaseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173807000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173807000Accu O2 Oxygen AnalyzerPrecision Medical, Inc.2018-05-02CCL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855887006870PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855887006870008558870068708558870068700855887006870

GMDN Terms#

Term, Definition table
TermDefinition
Respiratory oxygen monitor, battery-poweredA battery-powered instrument designed to continuously measure the concentration of oxygen (O2) inspired by a patient in a respiratory maintenance/therapy setting (e.g., O2 in an anaesthesia or ventilator breathing circuit, oxygen tent, oxygen therapy device/system tubing). It typically consists of an electronic unit with a display to show actual values of percentage of O2 concentration, a sensor to detect the O2 values, control knobs or buttons, and an alarm to alert when O2 values are beyond a predetermined range.

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
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10889483588673Vital Signs™AirLife Finland OyCCL2025-03-31
10889483588697Vital Signs™AirLife Finland OyCCL2025-03-31
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CCL2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CCL2024-12-19
00817770025856MaxBlend2MAXTEC, LLCCCL2024-08-14
10841522108846UltraviewSPACELABS HEALTHCARE (WASHINGTON), INCCCL2024-05-13
10190752191235Vital Signs™AirLife Finland OyCCL2023-05-30
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyCCL2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyCCL2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyCCL2023-04-19
00195278524089NAGE Healthcare Finland OyCCL2023-04-19
00840682146111CARESCAPE B650GE Healthcare Finland OyCCL2022-05-13
00840682146135CARESCAPE B450GE Healthcare Finland OyCCL2022-05-13
00840682146142CARESCAPE B850GE Healthcare Finland OyCCL2022-05-13
00840682146708NAGE Medical Systems Information Technologies, Inc.CCL2022-04-12
00840682146715NAGE Medical Systems Information Technologies, Inc.CCL2022-04-12
00840682146791NAGE Medical Systems Information Technologies, Inc.CCL2022-04-12
00840682147217NAGE Medical Systems Information Technologies, Inc.CCL2022-04-12
00840682147224NAGE Medical Systems Information Technologies, Inc.CCL2022-04-12
00840682104302NAGE Healthcare Finland OyCCL2022-03-07
10190752111349Vital Signs™Vyaire GmbHCCL2021-04-02
10190752143777Vital Signs™AirLife Finland OyCCL2021-03-05
10190752143784Vital Signs™AirLife Finland OyCCL2021-03-05
10190752143791Vital Signs™AirLife Finland OyCCL2021-03-05
10190752140844Vital Signs™AirLife Finland OyCCL2021-01-28
10190752140912Vital Signs™AirLife Finland OyCCL2021-01-28
10190752141827Vital Signs™AirLife Finland OyCCL2021-01-28