FDA.reportPublic FDA data

INOmax

Primary DI
00810055280117
Brand
INOmax
Company
Mallinckrodt Manufacturing LLC
Model
50383
Device description
Evolve Bunnell Life Pulse Conv Pack with Natvar
Published
2024-03-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZOSet, Tubing And Support, Ventilator (W Harness)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZOSet, Tubing And Support, Ventilator (W Harness)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810055280114PackageGS15In Commercial Distribution
00810055280117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081005528011410810055280114
00810055280117008100552801178100552801170810055280117

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 Pressure57 KiloPascal110 KiloPascal
Storage Environment Humidity15 millibar95 millibar
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
828331780
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810055281244INOmax811242024-08-19
00810055280100INOmax503722024-03-29
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
00810055280902INOmax810902023-05-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719874950637Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874950644Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874950651Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874951139Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874951146Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874957483Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874957919Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874959128Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874959487Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874959494Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874959500Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874959517Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
04719874959524Create BiotechCREATE BIOTECH CO., LTD.BZO2026-07-21
09420012402691Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-03-26
09420012433756Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-03-26
10197344011346HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
10197344011353HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
10197344011377HUDSON RCIMEDLINE INDUSTRIES, INC.BZO2026-03-13
09420012479105F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479129F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479143F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
09420012479167F&P OptiPAP JuniorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2026-01-23
10889483225653AirLife™SUNMED, LLCBZO2025-12-19
09420012414885AdaptorFISHER & PAYKEL HEALTHCARE LIMITEDBZO2025-10-07
14026704929099GIBECKTELEFLEX INCORPORATEDBZO2025-07-30
14026704660978HUDSON RCITELEFLEX INCORPORATEDBZO2025-07-07
10889483570555AirLife™AIRLIFEBZO2025-03-27
10889483571675AirLife™AIRLIFEBZO2025-03-27
10889483571682AirLife™AIRLIFEBZO2025-03-27
10889483571699AirLife™AIRLIFEBZO2025-03-27