FDA.reportPublic FDA data

Newport Medical

Primary DI
10884521542471
Brand
Newport Medical
Company
Newport Medical Instruments, Inc.
Model
PBC465A
Device description
REUSABLE PED CIRCUIT W/O PROX
Published
2018-08-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAICircuit, breathing (w connector, adaptor, y piece)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521542471PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452154247110884521542471

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator breathing circuit, reusableAn assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator, or other air-delivery therapeutic device such as a mechanical insufflator/exsufflator, to a patient. It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00;

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
Premarket exempt
true
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
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
10884521542051NewportHT70M-ES-EU2015-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10889483585627Vital Signs™AIRLIFECAI2025-02-17
10889483585801Vital Signs™AIRLIFECAI2025-02-17
10889483584699Vital Signs™AIRLIFECAI2025-02-11
10889483592175Vital Signs™AIRLIFECAI2025-02-11
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