FDA UDI
Not in Commercial Distribution
🇺🇸 United States
TOTOKU
DI: 04996005102893
·
Model: MS55i2/AR
·
JVC KENWOOD CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- TOTOKU
- Primary DI
- 04996005102893
- Version / Model
- MS55i2/AR
- Company Name
- JVC KENWOOD CORPORATION
- Labeler DUNS
- 713321040
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-01
- Public Version
- 7
- Public Version Date
- 2024-12-10
- Public Version Status
- Update
- Public Device Record Key
- 67029563-87f0-4891-a500-28f8b365b05b
- Distribution End Date
- 2018-11-30
Device Description
5MP Monochrome LCD Monitor ML21055-B1F0U
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| PGY | Display, Diagnostic Radiology | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36615 | Image display unit, monochrome | An electrically-powered visual display unit (VDU), commonly known as a screen or a monitor [e.g., cathode-ray tube (CRT) or liquid crystal display (LCD)], designed for displaying graphical information (e.g., values or images measured/acquired by other devices) in only one colour. The device(s) that generates the visual data is not included with the display unit. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04996005102893 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160326 | 000 |