Mistral-Air

GUDID ET37MA3400PM0

Mistral-Air® Premium Full Underbody - SYK

The Surgical Company International B.V.

Circulating-air whole-body heating/cooling system pad, single-use, non-sterile

• Primary Device ID: ET37MA3400PM0
• NIH Device Record Key: 8bf59ca6-0bf5-441b-8882-42cd0d0a0c20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mistral-Air
• Version Model Number: MA3400-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: MR Unsafe
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	ET37MA3400PM0 [Primary]
HIBCC	ET37MA3400PM1 [Package]; Package: Box [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101705

FDA Product Code

• DWJ: System, Thermal Regulating

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-01-03

On-Brand Devices [Mistral-Air]

• 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