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

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
00810055280087INOmax502802024-03-29
00810055280094INOmax503122024-03-29
00810055281244INOmax811242024-08-19
00810055280100INOmax503722024-03-29
00810055280117INOmax503832024-03-29
00810055280131INOmax503872024-03-29
00810055280148INOmax908552024-03-29
00810055280155INOmax912702024-03-29
00810055280063INOmax100952024-03-29
00810055280070INOmax101072024-03-29
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