FDA.reportPublic FDA data

INOmax

Primary DI
00810055280094
Brand
INOmax
Company
Mallinckrodt Manufacturing LLC
Model
50312
Device description
Evolve eINOcal Module
Published
2024-03-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K222930000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222930000Evolve Nitric Oxide Delivery SystemMallinckrodt Manufacturing, LLC2023-12-06MRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810055280091PackageGS124In Commercial Distribution
20810055280098PackageGS148In Commercial Distribution
00810055280094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081005528009110810055280091
2081005528009820810055280098
00810055280094008100552800948100552800940810055280094

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
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
828331780
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810055280087INOmax502802024-03-29
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
00810055280902INOmax810902023-05-10

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
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
00850000962262GENOSYL®VERO BIOTECH INC.MRN2023-10-06
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
00850000962101GENOSYL®VERO BIOTECH INC.MRN2023-07-24