FDA UDI
Not in Commercial Distribution
🇺🇸 United States
moorFLPI-2 Clinical PC Software
DI: 15060484490157
·
Model: 1
·
MOOR INSTRUMENTS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- moorFLPI-2 Clinical PC Software
- Primary DI
- 15060484490157
- Version / Model
- 1
- Company Name
- MOOR INSTRUMENTS LIMITED
- Labeler DUNS
- 398037580
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-13
- Public Version
- 2
- Public Version Date
- 2022-07-04
- Public Version Status
- Update
- Public Device Record Key
- 47fad94a-8e96-4962-aff4-d5d73e7b05d4
- Distribution End Date
- 2022-07-01
Device Description
moorFLPI-2 Clinical PC Software V1
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 |
|---|---|---|---|---|
| DPT | Probe, Blood-Flow, Extravascular | Cardiovascular | 870.2120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58447 | Cutaneous microcirculation laser Doppler imaging device | A mobile, mains electricity (AC-powered) device designed to use the laser Doppler imaging (LDI) technique of skin blood flow to visualize the perfusion of cutaneous microcirculation over a surface area. It typically consists of a dedicated camera system which includes a laser, an imaging sensor and electronics, mounted on a wheeled pedestal. The device works by non-invasively detecting the frequency change of the laser radiation reflected by the moving red blood cells in the small vessels. It is used in pre-, intra- [in the operating room (OR)], and postoperative clinical assessment, typically to evaluate burn wound healing potential, or for assessing reperfusion of cutaneous flaps. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15060484490157 | GS1 |
Customer Contacts
- Phone
- +44129735715
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K122943 | 000 |