FDA.reportPublic FDA data

Newport Medical

Primary DI
10884521542389
Brand
Newport Medical
Company
Newport Medical Instruments, Inc.
Model
OM1001P
Device description
Oxygen Analyzer
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K973282000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973282000HANDI OXYGEN ANALYZERCeramatec, Inc.1998-03-04CCL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521542389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452154238910884521542389

GMDN Terms#

Term, Definition table
TermDefinition
Respiratory oxygen monitor, line-poweredA mains electricity (AC-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; it may also include appropriate temperature-compensated electrodes.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height2.91Inch
Length1.44Inch
Width0.9Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
050334275
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521510838NewportE360T-ES-NA2019-08-17
10884521544338NewportHT70PM-PT-BR2018-01-31
10884521542204NewportHT70PM-PT-BR2015-10-22
10884521510845NewportE360T-US-NA2019-07-15
10884521541207NewportE360T-ES-NA2015-10-22
10884521541306NewportE360T-US-NA2015-10-22
10884521510647NewportE360E-SY-IN2023-05-01
10884521540965NewportE360E-SY-IN2015-10-22
10884521543928NewportHT70M-ES-NA2018-01-31
10884521542471Newport MedicalPBC465A2018-08-19
10884521542396Newport MedicalPBC335J2018-02-01
10884521541313NewportE360T-WW-IN2015-10-22
10884521544307NewportHT70PM-ES-NA2018-01-31
10884521542181NewportHT70PM-ES-NA2015-10-22
10884521542273NewportHT70PM-WW-UK2015-10-22
10884521540989NewportE360E-WW-IN2015-10-22
10884521510586NewportE360T-BR-BR2019-08-17
10884521510807NewportE360T-SY-IN2019-08-17
10884521544291NewportHT70PM-ES-EU2018-01-31
10884521544376NewportHT70PM-SY-NA2018-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyCCL2026-04-15
10889483588635Vital Signs™AirLife Finland OyCCL2025-04-02
10889483588659Vital Signs™AirLife Finland OyCCL2025-03-31
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