AccessGUDID - DEVICE: MULTIX SOLUTIONS SRL (G035018MLTACC0)

GUDID

Device Identifier (DI) Information

Brand Name: MULTIX SOLUTIONS SRL
Version or Model: ACCESSORY
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 018MLTACC
Company Name: MULTIX SOLUTIONS SRL

Primary DI Number: G035018MLTACC0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 435827526 *Terms of Use

Device Description: MEDICAL SOCKET SUPPORT

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?
40596	Electromechanical device/system transport trolley	A mobile (on wheels) cart intended to be used as a carrier for transporting an electromechanical device(s) or a powered system assembly. This trolley (cart) may be designed specifically for a proprietary control unit/system, and will typically have one or more horizontal surfaces where the devices are placed; it may include additional features (e.g., gas cylinder holder, intravenous pole) specific to a proprietary system. Neither electromechanical devices nor system components are included.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Storage Environment Humidity: between 5 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8a4d75a1-9a68-44ce-ae0d-0c8c8105d442
Public Version Date: October 06, 2023
Public Version Number: 1
DI Record Publish Date: September 28, 2023