FDA UDI In Commercial Distribution 🇺🇸 United States

Key ASIC Berhad

DI: G597KC00000B4000 · Model: Mcard · KEY ASIC BERHAD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Key ASIC Berhad
Primary DI
G597KC00000B4000
Version / Model
Mcard
Catalog Number
KC00000B400
Company Name
KEY ASIC BERHAD
Labeler DUNS
894326677
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-02-21
Public Version
1
Public Version Date
2024-02-29
Public Version Status
New
Public Device Record Key
dd5c1afb-7838-4e47-a1d2-1ff73e218044

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

Single Use
No
Prescription Use (Rx)
No
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
Yes
Has Serial Number
No
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
OUG Medical Device Data System

GMDN Terms

Code Name
62804 Data storage card

Identifiers

Type ID
Primary G597KC00000B4000