Primary Device ID | 18719867001547 |
NIH Device Record Key | c0db5cc7-4ed8-441f-a07d-4639ce01fb5d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Mistral-Air |
Version Model Number | MA5200-PM |
Company DUNS | 409656493 |
Company Name | The Surgical Company International B.V. |
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 | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Device Issuing Agency | Device ID |
---|---|
GS1 | 18719867001547 [Primary] |
DWJ | System, Thermal Regulating |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-05-27 |
Device Publish Date | 2022-05-19 |
ET375250PM0 | MA1200 Trolley - SYK |
ET37MA3450PM0 | Mistral-Air® Premium Half Underbody - SYK |
ET37MA3400PM0 | Mistral-Air® Premium Full Underbody - SYK |
ET37MA3365PM1 | Mistral-Air® Premium Half Upper Body - SYK |
ET37MA3360PM1 | Mistral-Air® Premium Upper Body - SYK |
ET37MA3350PM1 | Mistral-Air® Premium Lower Body - SYK |
ET37MA3340PM1 | Mistral-Air® Premium Neonatal - SYK |
ET37MA3330PM1 | Mistral-Air® Premium Paediatric - SYK |
ET37MA2475PM0 | Mistral-Air® Paediatric Underbody Plus - SYK |
ET37MA2450PM0 | Mistral-Air® Half Underbody Plus – SYK |
ET37MA2400PM0 | Mistral-Air® Full Underbody Plus – SYK |
ET37MA2290PM0 | Mistral-Air® Blanket, Surgical Access Plus - SYK |
ET37MA2286PM0 | Mistral-Air Blanket, Cardiac Blanket Plus (sterile) - SYK |
ET37MA2285PM0 | Mistral-Air Blanket, Lower Surgical Access Plus (sterile) - SYK |
ET37MA2280PM0 | Mistral-Air Blanket, Surgical Access Plus (sterile) - SYK |
ET37MA2270PM0 | Mistral-Air® Torso Plus - SYK |
ET37MA2265PM0 | Mistral-Air® Half Upper Body Plus – SYK |
ET37MA2260PM0 | Mistral-Air® Upper Body Plus – SYK |
ET37MA2250PM0 | Mistral-Air® Lower Body Plus – SYK |
ET37MA2240PM0 | Mistral-Air® Neonatal Plus – SYK |
ET37MA2230PM0 | Mistral-Air® Paediatric Plus – SYK |
ET37MA2220PM0 | Mistral-Air® Adult Plus – SYK |
ET37MA1740PM0 | Mistral-Air® Warming Suit, XL - SYK |
ET37MA1730PM0 | Mistral-Air® Warming Suit, L - SYK |
ET37MA1720PM0 | Mistral-Air® Warming Suit, M/L - SYK |
ET37MA1710PM0 | Mistral-Air® Warming Suit, S – SYK |
ET37MA1640PM0 | Mistral-Air® Premium Warming Suit, X Large - SYK |
ET37MA1630PM0 | Mistral-Air® Premium Warming Suit, Large - SYK |
ET37MA1620PM0 | Mistral-Air® Premium Warming Suit, Medium - SYK |
ET37MA1610PM0 | Mistral-Air® Premium Warming Suit, Small - SYK |
ET37MA1200PM0 | Mistral-Air® Warming Unit - SYK |
ET37MA1100PM0 | Mistral-Air® Plus Warming Unit - SYK (110-120V) |
ET37MA0510PM0 | Mistral-Air® Tube - SYK |
ET37MA0450PM0 | Mistral-Air® Underbody Reflective - SYK |
ET37MA0400PM0 | Mistral-Air® Full Underbody Reflective - SYK |
ET37MA0365PM0 | Mistral-Air® Half Upper Body Reflective - SYK |
ET37MA0360PM0 | Mistral-Air® Upper Body Reflective - SYK |
ET37MA0350PM0 | Mistral-Air® Lower Body Reflective - SYK |
ET37MA0340PM0 | Mistral-Air® Neonatal Reflective - SYK |
ET37MA0330PM0 | Mistral-Air® Paediatric Reflective - SYK |
ET37MA0320PM0 | Mistral-Air® Adult Reflective - SYK |
ET37MA02010PM0 | Mistral-Air® Faceshield – SYK |
18719867001547 | Mistral-Air® Adjustable Pole - SYK |
18719867001400 | Mistral-Air® Premium Half Underbody - SYK |
18719867001370 | Mistral-Air® Premium Full Underbody - SYK |
18719867001332 | Mistral-Air® Premium Half Upper Body - SYK |
18719867001295 | Mistral-Air® Premium Upper Body - SYK |
18719867001240 | Mistral-Air® Premium Lower Body - SYK |
18719867001219 | Mistral-Air® Premium Neonatal - SYK |
18719867001172 | Mistral-Air® Premium Paediatric - SYK |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() MISTRAL-AIR 85186399 4008906 Live/Registered |
The Surgical Company International B.V. 2010-11-29 |
![]() MISTRAL-AIR 79062248 not registered Dead/Abandoned |
The Surgical Company International B.V. 2008-09-19 |