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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OUG | Medical Device Data System | General Hospital | 880.6310 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G597KC00000B4000 | HIBCC |