INOblender

GUDID 00867538000120

INOblender

Mallinckrodt Manufacturing LLC

Nitric oxide delivery unit, system-based
Primary Device ID00867538000120
NIH Device Record Key682c6202-bcf8-4ce0-b1ff-050d3e37fa57
Commercial Distribution StatusIn Commercial Distribution
Brand NameINOblender
Version Model Number10004
Company DUNS828331780
Company NameMallinckrodt Manufacturing LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)566-9466
EmailCritCare-csmail@mallinckrodt.com

Operating and Storage Conditions

Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100867538000120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MROAPPARATUS, NITRIC OXIDE, BACKUP DELIVERY

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-11

Devices Manufactured by Mallinckrodt Manufacturing LLC

00810055280063 - INOmax2024-04-08 Evolve System Assembly US
00810055280070 - INOmax2024-04-08 Evolve Cart US
00810055280087 - INOmax2024-04-08 Evolve Injector Module
00810055280094 - INOmax2024-04-08 Evolve eINOcal Module
10810055280107 - INOmax2024-04-08 EVOLVE PRE-USE CHECKOUT KIT, BCG
10810055280114 - INOmax2024-04-08 Evolve Bunnell Life Pulse Conv Pack with Natvar
10810055280138 - INOmax2024-04-08 Evolve Sensormedics 3100A/B UnFiltered Conv Pac
10810055280145 - INOmax2024-04-08 Evolve Injector Tube

Trademark Results [INOblender]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INOBLENDER
INOBLENDER
79026694 3242739 Live/Registered
AGA AB
2006-04-04
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