FDA UDI
In Commercial Distribution
🇺🇸 United States
Moor Instruments Ltd
DI: 15060484490072
·
Model: moorLDI2-BI
·
MOOR INSTRUMENTS LIMITED
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Moor Instruments Ltd
- Primary DI
- 15060484490072
- Version / Model
- moorLDI2-BI
- Company Name
- MOOR INSTRUMENTS LIMITED
- Labeler DUNS
- 398037580
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-08
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- b675d08a-dbb9-45a8-9c8f-5a1fa07f3cd3
Device Description
moorLDI2-BI - Laser Doppler Imager, Burns Imaging System
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
- 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 |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
| 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 | 15060484490072 | GS1 |
Customer Contacts
- Phone
- +44129735715
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K060976 | 000 |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 86 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 50 Degrees Celsius