Mistral-Air

Basic Information

• Brand Name: Mistral-Air
• Primary DI: 18719867000038
• Version / Model: MA1100-PM
• Company Name: The Surgical Company International B.V.
• Labeler DUNS: 409656493
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-19
• Public Version: 2
• Public Version Date: 2022-10-24
• Public Version Status: Update
• Public Device Record Key: 77cac53a-6f19-4833-b172-e1af2c555e03

Device Description

Mistral-Air® Plus Warming Unit - SYK (110-120V)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DWJ	System, Thermal Regulating	Cardiovascular	870.5900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36954	Circulating-air whole-body heating system control unit	A mains electricity (AC-powered) device intended to be used as part of a circulating-air whole-body heating system to filter, and control/regulate the temperature and flow of room air through a connected patient-applied pad (not included), for heating a patient’s whole-body (i.e., elevate core body temperature to achieve normothermia). The device includes a filter, an air heater and air pump. It is intended to be used by a healthcare professional in a clinical setting.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	18719867000038	GS1

Premarket Submissions

Submission Number	Supplement Number
K101705	000