FDA.reportPublic FDA data

INOblender MRI

Primary DI
00867538000137
Brand
INOblender MRI
Company
Mallinckrodt Manufacturing LLC
Model
10077
Device description
INOblender MRI
Published
2016-09-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MROAPPARATUS, NITRIC OXIDE, BACKUP DELIVERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MROApparatus, Nitric Oxide, Backup DeliveryAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052663000
K122689000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052663000INO THERAPEUTICS INOBLENDER, MODEL 10004Ino Therapeutics2005-11-04MRO
K122689000INOBLENDERIno Therapeutics2012-11-07MRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00867538000137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00867538000137008675380001378675380001370867538000137

GMDN Terms#

Term, Definition table
TermDefinition
Nitric oxide delivery unit, system-basedA mains electricity (AC-powered) device, which may include internal rechargeable batteries, intended for the delivery of precise amounts of nitric oxide (NO), also known as nitrogen monoxide, to the respiratory tract of neonate, paediatric, and adult patients to treat severe respiratory disorders [e.g., primary pulmonary hypertension (PPH), acute respiratory distress syndrome (ARDS)]. It consists of a portable main unit that enables the delivery and monitoring of NO to gases that are to be breathed by the patient via a ventilator or other respiratory device/system. It typically includes accessory items (e.g., tubing, filters) and possibly a trolley (cart) for mobility.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure57 KiloPascal110 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure57 KiloPascal110 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)566-9466CritCare-csmail@mallinckrodt.com

Regulatory Flags#

DUNS number
828331780
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810055281244INOmax811242024-08-19
00810055280100INOmax503722024-03-29
00810055280117INOmax503832024-03-29
00810055280131INOmax503872024-03-29
00810055280148INOmax908552024-03-29
00810055280155INOmax912702024-03-29
00810055280063INOmax100952024-03-29
00810055280070INOmax101072024-03-29
00810055280087INOmax502802024-03-29
00810055280094INOmax503122024-03-29
10810055280107INOmax503722024-03-29
10810055280114INOmax503832024-03-29
10810055280138INOmax503872024-03-29
10810055280145INOmax908552024-03-29
10810055280152INOmax912702024-03-29
00810055280162INOmax503702024-03-29
00810055280179INOmax503712024-03-29
00810055280896INOmax811242023-05-10
00810055280865INOmax810862023-05-10
00810055280872INOmax810872023-05-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760333380671Ulspira TSAirgas Therapeutics, LLCMRO2024-01-02
00810055285037INOmaxMallinckrodt Manufacturing LLCMRO2023-02-01
00810055285051INOmaxMallinckrodt Manufacturing LLCMRO2023-02-01
00810055285068INOmaxMallinckrodt Manufacturing LLCMRO2023-02-01
00810055285075INOmaxMallinckrodt Manufacturing LLCMRO2023-02-01
00810055285082INOmaxMallinckrodt Manufacturing LLCMRO2023-02-01
00810055285099INOmaxMallinckrodt Manufacturing LLCMRO2023-02-01
15060541640112NOxBOXiNOXBOX LTDMRO2018-11-05
15060541640129NOxBOXiNOXBOX LTDMRO2018-11-05
15060541640136NOxBOXiNOXBOX LTDMRO2018-11-05
15060541640143NOxBOXiNOXBOX LTDMRO2018-11-05
05060541640030NOxBOXiNOXBOX LTDMRO2018-11-05
05060541640047NOxBOXiNOXBOX LTDMRO2018-11-05
05060541640054NOxBOXiNOXBOX LTDMRO2018-11-05
05060541640061NOxBOXiNOXBOX LTDMRO2018-11-05
05060541640078NOxBOXiNOXBOX LTDMRO2018-11-05
05060541640085NOxBOXiNOXBOX LTDMRO2018-11-05
15060541640167NOxBOXiNOXBOX LTDMRO2018-11-05
05060541640016NOxBOXiNOXBOX LTDMRO2018-11-05
05060541640023NOxBOXiNOXBOX LTDMRO2018-11-05
05060541640184NOxBOXiNOXBOX LTDMRO2018-11-05
05060541640191NOxBOXiNOXBOX LTDMRO2018-11-05
00867538000106INOmax DSIR PlusMallinckrodt Manufacturing LLCMRO2016-09-11
00867538000113INOmax DSIR Plus MRIMallinckrodt Manufacturing LLCMRO2016-09-11
00867538000120INOblenderMallinckrodt Manufacturing LLCMRO2016-09-11