FDA.reportPublic FDA data

Newport

Primary DI
10884521544376
Brand
Newport
Company
Newport Medical Instruments, Inc.
Model
HT70PM-SY-NA
Device description
HT70 Ventilator with Accessories Plus Model
Published
2018-10-14
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
CBKVENTILATOR, CONTINUOUS, FACILITY USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBKVentilator, Continuous, Facility UseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111146000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111146000NEWPORT HT70 VENTILATORNewport Medical Instruments, Inc.2011-12-01CBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521544376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452154437610884521544376

GMDN Terms#

Term, Definition table
TermDefinition
Neonatal/adult intensive-care ventilatorA mains electricity (AC-powered) automatic cycling device intended to provide long-term alveolar ventilation support for the full age-range of patients, from neonatal, paediatric to adult, in a critical care setting. It typically uses positive pressure to deliver gas at normal breathing rates and tidal volumes through an endotracheal (ET) tube or tracheostomy, and consists of a breathing circuit, a control system, monitors, and alarms. The inhalation limb includes sites where inspired gas may be heated/humidified, and the exhalation limb includes an exhaust valve to release gas to the ambient air. It can be operated in several modes (e.g., assist/control, synchronized, patient triggered).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure0.5 KiloPascal1.06 KiloPascal
Handling Environment Atmospheric Pressure0.6 KiloPascal1.1 KiloPascal
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Atmospheric Pressure60 KiloPascal110 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-18 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00Fragile, Keep dry, This side up
Special Storage Condition, Specify00Fragile, Keep dry, This side up;
Storage Environment Atmospheric Pressure0.5 KiloPascal1.06 KiloPascal
Storage Environment Atmospheric Pressure0.6 KiloPascal1.1 KiloPascal
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Atmospheric Pressure60 KiloPascal110 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius65 Degrees Celsius

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
Serial number
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
10884521542051NewportHT70M-ES-EU2015-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344102655MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102662MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102679MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102686MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102693MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102709MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
09420012477477F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012477484F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012477491F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480446F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480460F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480484F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
08056814676223DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676247DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676254DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676261DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676377DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676384DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676391DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676407DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676360DIMARHMC PREMEDICAL SPACBK2025-03-20
10889483603987AirLife™AIRLIFECBK2025-02-26
10889483603994AirLife™AIRLIFECBK2025-02-26
10889483604007AirLife™AIRLIFECBK2025-02-26
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10889483604069AirLife™AIRLIFECBK2025-02-26
10889483604076AirLife™AIRLIFECBK2025-02-26
10889483604083AirLife™AIRLIFECBK2025-02-26
10889483604090AirLife™AIRLIFECBK2025-02-26