INOcal BOM-COM-0159
GUDID 00810055280025
INOcal 45 PPM NO Calibration Gas
Mallinckrodt Manufacturing LLC
Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based Nitric oxide delivery unit, system-based| Primary Device ID | 00810055280025 |
| NIH Device Record Key | 6d5cb41c-ebe7-4fa2-8dfb-2b8957994ec8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INOcal |
| Version Model Number | BOM-COM-0159 |
| Catalog Number | BOM-COM-0159 |
| Company DUNS | 015322416 |
| Company Name | Mallinckrodt Manufacturing LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| 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 |
Operating and Storage Conditions
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810055280025 [Primary] |
FDA Product Code
| BXK | Gas, Calibration (Specified Concentration) |
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 | 2022-07-26 |
| Device Publish Date | 2022-07-18 |
On-Brand Devices [INOcal]
| 00810055280056 | INOcal 10 PPM NO2 Calibration Gas |
| 00810055280025 | INOcal 45 PPM NO Calibration Gas |
Trademark Results [INOcal]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INOCAL 75124073 2109970 Live/Registered |
MALLINCKRODT HOSPITAL PRODUCTS IP LIMITE 1996-06-24 |
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