Mistral Air

GUDID ET37MA3320PM1

Mistral-Air® Premium Adult - SYK

The Surgical Company International B.V.

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

• Primary Device ID: ET37MA3320PM1
• NIH Device Record Key: d3e7996e-3b3c-40c3-aa53-c6a4c75e80bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mistral Air
• Version Model Number: MA3320-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	ET37MA3320PM0 [Primary]
HIBCC	ET37MA3320PM1 [Package]; Contains: ET37MA3320PM0; 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: 2016-11-16

On-Brand Devices [Mistral Air]

• ET37MA3475PM0: Mistral-Air® Premium Paediatric Underbody - SYK
• ET37MA3320PM1: Mistral-Air® Premium Adult - SYK
• 18719867001455: Mistral-Air® Premium Paediatric Underbody - SYK
• 18719867001134: Mistral-Air® Premium Adult - SYK
• 18719867001530: Mistral Air Pole