INOmax

Primary DI
00810055285105
Brand
INOmax
Company
Mallinckrodt Manufacturing LLC
Model
91359
Device description
Injector Module, INOmax, BCG, CE 2797
Published
2023-02-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional

Contact Domains#

Product Codes#

Code, Name table
CodeName
MRNApparatus, Nitric Oxide Delivery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRNApparatus, Nitric Oxide 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
00810055285105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810055285105008100552851058100552851050810055285105

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
Expiration date on label
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
00850018561297AeroNOx 2.0 Nitric Oxide Delivery DeviceINTERNATIONAL BIOMEDICAL, LTD.MRN2026-10-19
00850018561303AeroNOx 2.0 Nitric Oxide Delivery DeviceINTERNATIONAL BIOMEDICAL, LTD.MRN2026-10-19
00850018561624AeroNOx 2.0 Nitric Oxide Delivery DeviceINTERNATIONAL BIOMEDICAL, LTD.MRN2026-10-19
00850018561631AeroNOx 2.0 Nitric Oxide Delivery DeviceINTERNATIONAL BIOMEDICAL, LTD.MRN2026-10-19
00850018561655AeroNOx 2.0 Nitric Oxide Delivery DeviceINTERNATIONAL BIOMEDICAL, LTD.MRN2026-10-19
00850018561662AeroNOx 2.0 Nitric Oxide Delivery DeviceINTERNATIONAL BIOMEDICAL, LTD.MRN2026-10-19
00850018561679AeroNOx 2.0 Nitric Oxide Delivery DeviceINTERNATIONAL BIOMEDICAL, LTD.MRN2026-10-19
00850018561686AeroNOx 2.0 Nitric Oxide Delivery DeviceINTERNATIONAL BIOMEDICAL, LTD.MRN2026-10-19
00850018561693AeroNOx 2.0 Nitric Oxide Delivery DeviceINTERNATIONAL BIOMEDICAL, LTD.MRN2026-10-19
00810055280100INOmaxMallinckrodt Manufacturing LLCMRN2024-03-29
00810055280148INOmaxMallinckrodt Manufacturing LLCMRN2024-03-29
00810055280155INOmaxMallinckrodt Manufacturing LLCMRN2024-03-29
00810055280063INOmaxMallinckrodt Manufacturing LLCMRN2024-03-29
00810055280070INOmaxMallinckrodt Manufacturing LLCMRN2024-03-29
00810055280087INOmaxMallinckrodt Manufacturing LLCMRN2024-03-29
00810055280094INOmaxMallinckrodt Manufacturing LLCMRN2024-03-29
10810055280107INOmaxMallinckrodt Manufacturing LLCMRN2024-03-29
10810055280145INOmaxMallinckrodt Manufacturing LLCMRN2024-03-29
10810055280152INOmaxMallinckrodt Manufacturing LLCMRN2024-03-29
00810055280162INOmaxMallinckrodt Manufacturing LLCMRN2024-03-29
00810055280179INOmaxMallinckrodt Manufacturing LLCMRN2024-03-29
03760333380671Ulspira TSAirgas Therapeutics, LLCMRN2024-01-02
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00850000962279GENOSYL®VERO BIOTECH INC.MRN2023-10-06
00850000962286GENOSYL®VERO BIOTECH INC.MRN2023-10-06
00850000962293GENOSYL®VERO BIOTECH INC.MRN2023-10-06
00850000962309GENOSYL®VERO BIOTECH INC.MRN2023-10-06
00850000962323GENOSYL®VERO BIOTECH INC.MRN2023-10-06
00850000962019GENOSYL®VERO BIOTECH INC.MRN2023-07-24
00850000962064GENOSYL®VERO BIOTECH INC.MRN2023-07-24