AccessGUDID - DEVICE: Key ASIC Berhad (G597KC00000B4000)

GUDID

Device Identifier (DI) Information

Brand Name: Key ASIC Berhad
Version or Model: Mcard
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KC00000B400
Company Name: KEY ASIC BERHAD

Primary DI Number: G597KC00000B4000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 894326677 *Terms of Use

Device Description: The Mcard is a healthcare tool designed to store and transfer medical data, meeting the rigorous standards of the industry. With its robust and reliable features, this card ensures a seamless user experience for healthcare professionals.

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?
62804	Data storage card	A small electronic device designed to connect to a dedicated port of a computer, typically called a card slot, to download or upload saved data. Commonly known as a memory card or PC card, it is made of metal and plastic materials and typically has flat metal segmented contact points at one end to connect to computerized devices.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OUG	Medical Device Data System

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dd5c1afb-7838-4e47-a1d2-1ff73e218044
Public Version Date: February 29, 2024
Public Version Number: 1
DI Record Publish Date: February 21, 2024