FDA UDI
In Commercial Distribution
🇺🇸 United States
ELMED INCORPORATED
DI: 00198506086915
·
Model: 51800-23
·
ELMED INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ELMED INCORPORATED
- Primary DI
- 00198506086915
- Version / Model
- 51800-23
- Catalog Number
- 51800-23
- Company Name
- ELMED INCORPORATED
- Labeler DUNS
- 049290364
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-25
- Public Version
- 1
- Public Version Date
- 2025-12-03
- Public Version Status
- New
- Public Device Record Key
- cb00acf7-568d-472d-b939-e67e1a9d76a2
Device Description
HD DIGITAL FLAT PANEL COLOR MONITOR, 23"
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FXM | Camera, Still, Endoscopic | General, Plastic Surgery | 878.4160 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56654 | Endoscopic video image display unit | An electrically-powered visual display unit (VDU), commonly known as a screen or a monitor, designed to be used exclusively in conjunction with a video endoscope to display to the operator the graphical information captured by the endoscope to facilitate its manipulation during the endoscopic procedure; typically difficult and non-difficult intubation procedures to maintain an open airway. It is typically a portable device with a liquid crystal display (LCD) colour screen and a direct electronic signal connection to the endoscope. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00198506086915 | GS1 |
Customer Contacts
- Phone
- 224-353-6446
- [email protected]