Mistral Air

GUDID 18719867001530

Mistral Air Pole

The Surgical Company International B.V.

External circulating-air core temperature regulation system pad, single-use

• Primary Device ID: 18719867001530
• NIH Device Record Key: 332fa96f-b9cb-4c97-be53-fa66258754c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mistral Air
• Version Model Number: MA5200
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	18719867001530 [Primary]

FDA Product Code

• DWJ: System, Thermal Regulating

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: 2025-02-07
• Device Publish Date: 2025-01-30

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