FDA UDI
In Commercial Distribution
🇺🇸 United States
Nexxis OR
DI: 05415334034280
·
Model: MNA-440
·
Barco NV
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Nexxis OR
- Primary DI
- 05415334034280
- Version / Model
- MNA-440
- Catalog Number
- K9350204X
- Company Name
- Barco NV
- Labeler DUNS
- 371618773
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-22
- Public Version
- 1
- Public Version Date
- 2021-04-30
- Public Version Status
- New
- Public Device Record Key
- dc1aec6c-030b-4eae-ac23-028d95590acf
Device Description
MNA-440 DEC HDMI V2 INC SFP+ XX
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
- Yes
- 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 |
|---|---|---|---|---|
| DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL | Cardiovascular | 870.2450 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58117 | Operating room audiovisual data/device management system | A mains electricity (AC-powered) device assembly designed to provide operating room (OR) staff with a single point of management to operate electromechanical/electronic medical devices of different makes during surgery. It is a computer-based integrated hardware/software application that typically consists of a base unit (outside the sterile field or the OR) to which all device cabling is connected, and software that runs on an off-the-shelf computer with a touchscreen (in the OR). The system is intended to manipulate devices such as OR lights, OR tables, cameras, video endoscope images, and monitors; it may also be used to manage patient data from these devices. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05415334034280 | GS1 |
Customer Contacts
- Phone
- +1(866)302-7939
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173381 | 000 |