INOmax
GUDID 00810055283514
TEE, O2 TUBING SAMPLE, NO BUSHING BCG, CE 2797
Mallinckrodt Manufacturing LLC
Nitric oxide delivery unit, system-based| Primary Device ID | 00810055283514 |
| NIH Device Record Key | 7e26d58c-0761-43e4-bdab-fab3ec63049b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INOmax |
| Version Model Number | 91351 |
| Company DUNS | 828331780 |
| Company Name | Mallinckrodt Manufacturing LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(877)566-9466 |
| CritCare-csmail@mnk.com | |
| Phone | +1(877)566-9466 |
| CritCare-csmail@mnk.com | |
| Phone | +1(877)566-9466 |
| CritCare-csmail@mnk.com | |
| Phone | +1(877)566-9466 |
| CritCare-csmail@mnk.com | |
| Phone | +1(877)566-9466 |
| CritCare-csmail@mnk.com | |
| Phone | +1(877)566-9466 |
| CritCare-csmail@mnk.com | |
| Phone | +1(877)566-9466 |
| CritCare-csmail@mnk.com | |
| Phone | +1(877)566-9466 |
| CritCare-csmail@mnk.com | |
| Phone | +1(877)566-9466 |
| CritCare-csmail@mnk.com | |
| Phone | +1(877)566-9466 |
| CritCare-csmail@mnk.com | |
| Phone | +1(877)566-9466 |
| CritCare-csmail@mnk.com | |
| Phone | +1(877)566-9466 |
| CritCare-csmail@mnk.com | |
| Phone | +1(877)566-9466 |
| CritCare-csmail@mnk.com | |
| Phone | +1(877)566-9466 |
| CritCare-csmail@mnk.com | |
| Phone | +1(877)566-9466 |
| CritCare-csmail@mnk.com | |
| Phone | +1(877)566-9466 |
| CritCare-csmail@mnk.com | |
| Phone | +1(877)566-9466 |
| CritCare-csmail@mnk.com | |
| Phone | +1(877)566-9466 |
| CritCare-csmail@mnk.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 15 Degrees Celsius and 95 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 15 Degrees Celsius and 95 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 15 Degrees Celsius and 95 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 15 Degrees Celsius and 95 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 15 Degrees Celsius and 95 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 15 Degrees Celsius and 95 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 15 Degrees Celsius and 95 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 15 Degrees Celsius and 95 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 15 Degrees Celsius and 95 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 15 Degrees Celsius and 95 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 15 Degrees Celsius and 95 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 15 Degrees Celsius and 95 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 15 Degrees Celsius and 95 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 15 Degrees Celsius and 95 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 15 Degrees Celsius and 95 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 15 Degrees Celsius and 95 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 15 Degrees Celsius and 95 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 110 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 15 Degrees Celsius and 95 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 110 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810055283514 [Primary] |
FDA Product Code
| MRN | Apparatus, Nitric Oxide Delivery |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-05-18 |
| Device Publish Date | 2023-05-10 |
On-Brand Devices [INOmax]
| 10810055284280 | LINE, MR PATIENT GAS SAMPLE & FILTER 16FT/5M BCG |
| 10810055284150 | Pack, Bunnell Life Pulse Disposable Adapters Convenience BCG, CE 2797 |
| 10810055284037 | LINE, PATIENT GAS SAMPLE & FILTER 10FT/3M BCG, CE |
| 10810055284020 | FILTER ASSEMBLY, HYDROPHOBIC, CE |
| 10810055283528 | TUBE, NO/N2 INJECTOR BCG, CE 2797 |
| 10810055283481 | LINE, PATIENT GAS SAMPLE, 10 FT/3 M WITH NAFION, BCG, CE |
| 10810055283474 | TEE, O2 TUBING SAMPLE BCG, CE 2797 |
| 10810055283443 | Adapter, 22M/15F X 22M/15F BCG, CE 2797 |
| 10810055280886 | ADAPTER, CUFF, 22mm ID X 22mm ID BCG, CE 2797 |
| 10810055280299 | ADAPTER, CUFF, 22mm ID X 22mm ID BCG, CE 2797 |
| 00810055280285 | ADAPTER, 22 mm OD X 10 mm OD BCG, CE 2797 |
| 00810055280278 | ADAPTER, GAS SAMPLE TEE BCG |
| 10810055280268 | ADAPTER, 22M/15F X 22M/15F BCG |
| 00810055280254 | ADAPTER, 22F X 15M BCG |
| 00810055285105 | Injector Module, INOmax, BCG, CE 2797 |
| 00810055285099 | INOmax Regulator ISO 5145 BOM (Right) |
| 00810055285082 | INOmax DSIR 800 ppm |
| 00810055285075 | INOblender NIST 800ppm |
| 00810055285068 | INOmax Transport Regulator/Cap ISO 5145 BOM |
| 00810055285051 | INOmax DSIR 400 ppm |
| 00810055285044 | Inomax transport regulator / cap assembly |
| 00810055285037 | INOblender NIST 400ppm |
| 00810055285020 | INOmax Regulator ISO 5145 BOM (Left) |
| 00810055285013 | INOmax Regulator Extension Hose |
| 00810055285006 | INOmax regulator CGA 626 |
| 00810055288458 | CELL, NO2 FUEL |
| 00810055288441 | CELL, NO FUEL |
| 10810055284174 | PACK, SENSORMEDICS 3100A/B FILTERED CIRCUIT DISPOSABLE ADPTRS CNVC BCG, CE 2797 |
| 10810055283535 | Adapter, 15M Fits 4.5 mm ID Tubing BCG, CE 2797 |
| 00810055283514 | TEE, O2 TUBING SAMPLE, NO BUSHING BCG, CE 2797 |
| 10810055283504 | Tube, MR NO/N2 Injector BCG |
| 10810055283498 | Disc Filter, Ø50mm, 1 micron glass fiber, BCG, CE |
| 10810055283467 | One-Way Valve, 22F X 22M |
| 10810055283450 | ADAPTER, 22F X 15M BCG, CE 2797 |
| 10810055283436 | Adapter, Gas Sample Tee BCG, CE 2797 |
| 10810055281241 | Extension, 15mm (6 inches) Pediatric |
| 00810055280988 | Tubing Kit,.187 X .312 X 10 Inch cut length, BCG, CE 2797 |
| 00810055280971 | ADAPTER, 22 mm OD X 10 mm OD BCG, CE 2797 |
| 00810055280964 | ADAPTER, 15M FITS 8.0 mm ID TUBING BCG, CE 2797 |
| 00810055280957 | ADAPTER, 22M/15F X 22M/15F (POLYCARBONATE) |
| 00810055280940 | VALVE, ONE-WAY, HIGH FLOW FITS 3/8 in TUBING, BARBED ENDS |
| 00810055280933 | VALVE, HIGH FLOW ONE-WAY, 3/16 in TUBING, CE 2797 |
| 10810055280923 | Line, 10ft patient gas sample BCG, CE |
| 10810055280916 | CARTRIDGE, INOvent WATER SEPARATOR, CE |
| 10810055280909 | ADAPTER, 22M/15F X 22M/15F GAS SAMPLE TEE, CE 2797 |
| 10810055280879 | Adapter, 90-deg Sample Port BCG, CE 2797 |
| 10810055280862 | Tubing, 10mm (2 pieces) Neonatal BCG |
| 00810055280193 | INOcal Regulator Accessory |
| 00810055280186 | INOcal Tubing Assembly |
| 00810055280896 | Extension, 15mm (6 inches) Pediatric |
Trademark Results [INOmax]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INOMAX 79026770 3280185 Live/Registered |
Therakos, Inc. 2006-04-04 |
 INOMAX 75342495 2185947 Live/Registered |
MALLINCKRODT HOSPITAL PRODUCTS IP LIMITED 1997-08-18 |
 INOMAX 74614450 not registered Dead/Abandoned |
OHMEDA PHARMACEUTICAL PRODUCTS DIVISIONINC. 1994-12-22 |
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