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510(k) Data Aggregation
K Number
K171234Device Name
Mistral-Air Warming Unit
Date Cleared
2017-05-26
(29 days)
Product Code
Regulation Number
870.5900Why did this record match?
Applicant Name (Manufacturer) :
The Surgical Company International BV (as The 37Company)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Mistral-Air® Warming System is a forced air warming device and comprises of a warming unit and a variety of blankets. It is intended to raise and maintain patient temperature by means of surface warming.
Device Description
The Mistral-Air® Warming System comprises of the following devices:
- One warming unit of models: ● MA1200-PM Mistral-Air® - SYK (forced air warming unit 100-125 V~, 50/60 Hz) c Connected to
- One warming blanket of models: Non-sterile Accessory: Stryker REF / Stryker Proprietary name MA02010-PM Faceshield - SYK Non-sterile blankets: Stryker REF / Stryker Proprietary name MA0220-PM / Adult White - SYK MA0230-PM / Paediatric White - SYK MA0250-PM / Lower Body White - SYK MA0260-PM / Upper Body White - SYK MA0265-PM / Half Upper Body White - SYK MA0270-PM / Torso White - SYK MA0290-PM / Surgical Access White - SYK MA0320-PM / Adult Reflective - SYK MA0330-PM / Paediatric Reflective - SYK MA0340-PM / Neonatal Reflective - SYK MA0350-PM / Lower Body Reflective - SYK MA0360-PM / Upper Body Reflective - SYK MA0365-PM / Half Upper Body Reflective - SYK MA0400-PM / Full Underbody Reflective - SYK MA0450-PM / Underbody Reflective - SYK MA0510-PM / Tube - SYK Sterile blankets: Stryker REF / Stryker Proprietary name MA0280-PM / Surgical Access White (sterile) - SYK MA0285A-PM / Lower Surgical Access White (sterile) - SYK MA0286-PM / Cardiac Blanket (sterile) - SYK Non-sterile blankets: Stryker REF / Stryker Proprietary name MA1610-PM / Premium Warming Suit S - SYK MA1620-PM / Premium Warming Suit M - SYK MA1630-PM / Premium Warming Suit L - SYK MA1640-PM / Premium Warming Suit XL - SYK MA1710-PM / Warming Suit S - SYK MA1720-PM / Warming Suit M - SYK MA1730-PM / Warming Suit L - SYK MA1740-PM / Warming Suit XL - SYK Non-sterile blankets: Stryker REF / Stryker Proprietary name MA2220-PM / Adult Plus - SYK MA2230-PM / Paediatric Plus - SYK MA2240-PM / Neonatal Plus - SYK MA2250-PM / Lower Body Plus - SYK MA2260-PM / Upper Body Plus - SYK MA2265-PM / Half Upper Body Plus - SYK MA2270-PM / Torso Plus - SYK MA2290-PM / Surgical Access Plus - SYK MA2400-PM / Full Underbody Plus - SYK MA2450-PM / Half Underbody Plus - SYK MA2475-PM / Paediatric Underbody Plus - SYK MA3320-PM / Premium Adult - SYK MA3330-PM / Premium Paediatric - SYK MA3340-PM / Premium Neonatal - SYK MA3350-PM / Premium Lower Body - SYK MA3360-PM / Premium Upper Body - SYK MA3365-PM / Premium Half Upper Body - SYK MA3400-PM / Premium Full Underbody - SYK MA3450-PM / Premium Half Underbody - SYK MA3475-PM / Premium Paediatric Underbody - SYK Sterile blankets: Stryker REF / Stryker Proprietary name MA2280-PM / Surgical Access Plus (sterile) - SYK MA2285-PM / Lower Surgical Access Plus (sterile) - SYK MA2286-PM / Cardiac Blanket Plus (sterile) - SYK
The principle of operation is an electrically powered forced air warming unit (consists of a control circuit, an air filter, a fan, a heating element and temperature sensors) that propels warmed air via a flexible hose to a warming blanket (sterile or non-sterile, depending on the model) draped over the patient. Some warming blankets allow for the patient to be placed on top of the blanket or surrounded by a warming tube. All warming blankets are intended for single patient use only.
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K Number
K101705Device Name
MISTRAL-AIR WARMING SYSTEM
Manufacturer
Date Cleared
2010-07-02
(15 days)
Product Code
Regulation Number
870.5900Why did this record match?
Applicant Name (Manufacturer) :
THE SURGICAL COMPANY INTERNATIONAL BV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Mistral-Air® Warming System is a forced air warming device and comprises of a warming unit and a variety of blankets. It is intended to raise and maintain patient temperature by means of surface warming.
Device Description
The Mistral-Air Warming System comprises of the following devices:
- MA1100-US Mistral-Air Plus Warming Unit 110-120V~, 60Hz .
- Mistral-Air Adult Blanket (white) MA0220 .
- Mistral-Air Paediatric Blanket (white) MA0230 .
- Mistral-Air Lower Body Blanket (white) MA0250 ●
- Mistral-Air Upper Body Blanket (white) MA0260 ●
- Mistral-Air Half Upper Body Blanket (white) MA0265 .
- Mistral-Air Torso Blanket (white) ● MA0270
- Mistral-Air Full Body Surgical Access Sterile (white) MA0280 .
- MA0290 Mistral-Air Full Body Surgical Access - Non-sterile (white) .
- Mistral-Air Adult Blanket (silver) MA0320 ◆
- Mistral-Air Paediatric Blanket (silver) MA0330
- Mistral-Air Neonatal Blanket (silver) MA0340 ●
- Mistral-Air Lower Body Blanket (silver) MA0350 ●
- Mistral-Air Upper Body Blanket (silver) MA0360
- Mistral-Air Half Upper Body Blanket (silver) MA0365
- MA0400 Mistral-Air Full Underbody (silver) .
- Mistral-Air Underbody (silver) MA0450 .
- Mistral-Air Tube (blue) MA0510
The principle of operation is an electrically powered unit (the Mistral-Air Plus Warming Unit) consisting of a fan and heating element that propels warmed air via a flexible hose to a blanket (the Mistral-Air Blanket) draped over the patient. Some configurations allow for the patient to be placed on top of the blanket or surrounded by a warming tube. Almost all types of Mistral-Air Blankets types are provided non-sterile. However, one type of Mistral-Air Blankets is provided sterile. The Mistral-Air Blankets (both non-sterile versions) are intended for single patient use only.
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