FDA.reportPublic FDA data

INOmax

Primary DI
10810055280299
Brand
INOmax
Company
Mallinckrodt Manufacturing LLC
Model
81126
Device description
ADAPTER, CUFF, 22mm ID X 22mm ID BCG, CE 2797
Published
2021-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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

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
10810055280299PackageGS15In Commercial Distribution
00810055280292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081005528029910810055280299
00810055280292008100552802928100552802920810055280292

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.

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
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

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Primary DI, Brand, Company table
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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
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