FDA.reportPublic FDA data

Newport Medical

Primary DI
10884521540811
Brand
Newport Medical
Company
Newport Medical Instruments, Inc.
Model
C235-120V-60-1
Device description
Air Compressor System, 120VAC, 60Hz, 5.6 Amp
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTICompressor, air, portable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTICompressor, Air, PortableAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091871000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091871000DK50 DSEkom S.R.O.2009-10-23BTI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521540811PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452154081110884521540811

GMDN Terms#

Term, Definition table
TermDefinition
Medical device air compressorA mains electricity (AC-powered) device designed to create compressed air and supply it directly to gas-powered or compressed air dependent devices (e.g., ventilators or other respiratory devices, laboratory equipment). It may also provide medical air depending upon the filtering systems employed.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00This side up;Fragile
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius55 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
10884521544376NewportHT70PM-SY-NA2018-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810050863438MedPakLIFEPORT, LLCBTI2026-05-06
00038214001773Pulmo-Mist CompressorNIDEK MEDICAL PRODUCTS, INC.BTI2026-04-20
00038214001780Pulmo-Mist Compressor NIDEK MEDICAL PRODUCTS, INC.BTI2026-04-20
00038214001797Pulmo-Mist Compressor NIDEK MEDICAL PRODUCTS, INC.BTI2026-04-20
00762860000582OMBRA* Table Top Compressor System Trudell Medical InternationalBTI2025-11-06
10197344149070MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-11-03
10197344149087MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-11-03
10197344149094MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-11-03
10197344149100MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-11-03
10197344135592MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-14
10197344135585MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-06
10197344154180MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-06
10197344154197MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-06
10197344154203MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-06
10197344135578MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-07-28
00197344042817MedlineMEDLINE INDUSTRIES, INC.BTI2024-02-16
00810050862745Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2024-01-11
00810050862707Utility Pedestal AssemblyLIFEPORT, LLCBTI2023-12-15
00810050862691Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-12-08
00810050862677Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-11-10
00810050862615Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-10-23
00810050862622Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-10-23
00810050862523Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-08-23
00810050862530Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-08-23
00810050862547Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-08-23
00810050862431Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-06-06
00810050862363Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-03-16
00810050862370Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-03-16
00810050862325Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-02-07
00810050862332Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-02-07