AccessGUDID - DEVICE: Mistral-Air (ET37MA5250PM0)

GUDID

Device Identifier (DI) Information

Brand Name: Mistral-Air
Version or Model: MA5250-PM
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: The Surgical Company International B.V.

Primary DI Number: ET37MA5250PM0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 409656493 *Terms of Use

Device Description: MA1200 Trolley - SYK

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36801	Utility trolley	A cart designed for transporting/supplying general-purpose goods, devices, medical equipment, or supplies within a hospital/institution department or ward. This trolley (cart) may have one or more open platforms and may have a handle(s) for pushing the trolley.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DWJ	System, Thermal Regulating

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between -40 and 70 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4c03c4c9-6ff8-4725-a8d7-7fc7a61a0b74
Public Version Date: October 21, 2024
Public Version Number: 4
DI Record Publish Date: August 07, 2017