Primary Device ID | 00867538000137 |
NIH Device Record Key | cb000142-e07a-4715-8dfe-dc5cf8e4ecfd |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | INOblender MRI |
Version Model Number | 10077 |
Company DUNS | 828331780 |
Company Name | Mallinckrodt Manufacturing LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Conditional |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(877)566-9466 |
CritCare-csmail@mallinckrodt.com |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00867538000137 [Primary] |
MRO | APPARATUS, NITRIC OXIDE, BACKUP DELIVERY |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-11 |
00810055280063 - INOmax | 2024-04-08 Evolve System Assembly US |
00810055280070 - INOmax | 2024-04-08 Evolve Cart US |
00810055280087 - INOmax | 2024-04-08 Evolve Injector Module |
00810055280094 - INOmax | 2024-04-08 Evolve eINOcal Module |
10810055280107 - INOmax | 2024-04-08 EVOLVE PRE-USE CHECKOUT KIT, BCG |
10810055280114 - INOmax | 2024-04-08 Evolve Bunnell Life Pulse Conv Pack with Natvar |
10810055280138 - INOmax | 2024-04-08 Evolve Sensormedics 3100A/B UnFiltered Conv Pac |
10810055280145 - INOmax | 2024-04-08 Evolve Injector Tube |