FDA.reportPublic FDA data

AeroNOx Nitric Oxide Delivery Device

Primary DI
00868406000068
Brand
AeroNOx Nitric Oxide Delivery Device
Company
INTERNATIONAL BIOMEDICAL, LTD.
Model
AeroNOx
Catalog number
731-9148
Device description
Nitric Oxide Delivery Device
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K093260000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093260000AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEMInternational Biomedical, Ltd.2009-12-16MRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868406000068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868406000068008684060000688684060000680868406000068

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5128730033sales@int-bio.com

Regulatory Flags#

DUNS number
073179368
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850018561297AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx Delivery Lines415-00012026-10-19
00850018561303AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx Sample Lines415-00002026-10-19
00850018561624AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx INOstat Bagger415-00022026-10-19
00850018561631AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx Bagger731-99192026-10-19
00850018561655AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx NO Supply Hose731-18622026-10-19
00850018561662AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx Calibration Kit731-02742026-10-19
00850018561679AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx Test Circuit738-18892026-10-19
00850018561686AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx Calibration Circuit738-18502026-10-19
00850018561693AeroNOx 2.0 Nitric Oxide Delivery DeviceAeroNOx INOstat Kit731-91472026-10-19
00850018561006ECG Patient CableECG Patient Cable711-00142026-10-13
00850018561037Gel-E DonutGEL-E DONUT, MEDIUM (CASE OF 12)9898031963912026-10-13
00850018561044Gel-E DonutGEL-E DONUT, EXTRA SMALL (CASE OF 12)9898031963712026-10-13
00850018561051Gel-E DonutGEL-E DONUT, SMALL (CASE OF 12)9898031963812026-10-13
00850018561068SquishonSquishon 2 Gel Pillow, 12/pk9898031963612026-10-13
00850018561075SquishonSquishon Mattress9898056033012026-10-13
00850018561082SquishonSquishon 3 Gel Pillow, 12/pk9898056064612026-10-13
00850018561105WeeSpecsWeeSpecs, Small (28-34 cm), 50/pk9898056076412026-10-13
00850018561136WeeSpecsWeeSpecs Supreme Small, 50/pk9898056041612026-10-13
00850018561143WeeSpecsWeeSpecs Supreme, Medium, 50/pk9898056042112026-10-13
00850018561150WeeSpecsWeeSpecs Supreme, Preemie, 50/pk9898056076312026-10-13

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
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00810055280063INOmaxMallinckrodt Manufacturing LLCMRN2024-03-29
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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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