FDA.reportPublic FDA data

INOmax

Primary DI
00810055285037
Brand
INOmax
Company
Mallinckrodt Manufacturing LLC
Model
10021
Device description
INOblender NIST 400ppm
Published
2023-02-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K131686000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131686000INOMAX DSIR (DELIVERY SYSTEM)Ino Therapeutics/Ikaria2013-11-29MRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810055285037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810055285037008100552850378100552850370810055285037

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 Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)566-9466CritCare-csmail@mnk.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
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
00867538000137INOblender MRIMallinckrodt Manufacturing LLCMRO2016-09-11