FDA UDI
In Commercial Distribution
🇺🇸 United States
moorVMS-TREND PC Software
DI: 15060484490164
·
Model: 1
·
MOOR INSTRUMENTS LIMITED
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- moorVMS-TREND PC Software
- Primary DI
- 15060484490164
- Version / Model
- 1
- Company Name
- MOOR INSTRUMENTS LIMITED
- Labeler DUNS
- 398037580
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-31
- Public Version
- 1
- Public Version Date
- 2019-11-08
- Public Version Status
- New
- Public Device Record Key
- a0ed9694-6e58-4375-a189-4125ff058975
Device Description
moorVMS-TREND PC software is intended for use with moorVMS-LDF and moorVMS-OXY, for long term blood flow and tissue oxygen trend monitoring. It is intended for a variety of physiological and clinical research applications in clinical settings. The clinical value of measurements in disease states has not been established. The moorVMS-TREND is not intended to be used as the sole basis for diagnosis or therapy. The moorVMS-TREND Software is not intended for critical care monitoring where loss of function could result in harm to the patient.
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| MUD | Oximeter, Tissue Saturation | Cardiovascular | 870.2700 | 2 |
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46615 | Tissue saturation oximeter | A mains electricity (AC-powered) photoelectric device that noninvasively calculates the percent oxygen saturation of haemoglobin in a volume of tissue (StO2) to assess the amount of oxygen delivered to that tissue, typically during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation. The device typically includes a monitor for data analysis and display, a light-transmitting cable, and a tissue-surface sensor. | No | Active |
| 60451 | Laser Doppler blood flowmeter | A mobile, mains electricity (AC-powered) device designed to use laser Doppler techniques to measure the velocity of micro- and macrovascular blood circulation to assess of the extent of vascular flow restrictions [e.g., clots, stenosis, mechanical damage, and peripheral vascular disease (PVD)]. It typically measures blood flow/perfusion, transcutaneous oxygen (TCOM) and/or carbon dioxide, and may have modules for heat provocation and pressure control. It typically consists of various laser Doppler probes, temperature measurement sensors, and pressure measuring cuff/sensors connected to a software-controlled control/visual display unit. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15060484490164 | GS1 |
Customer Contacts
- Phone
- +44129735715
- [email protected]