FDA UDI
In Commercial Distribution
🇺🇸 United States
Moor Instruments Ltd
DI: 15060484490140
·
Model: NON-STERILE OXYGENATION AND LASER DOPPLER COMBINED PROBES
·
MOOR INSTRUMENTS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Moor Instruments Ltd
- Primary DI
- 15060484490140
- Version / Model
- NON-STERILE OXYGENATION AND LASER DOPPLER COMBINED PROBES
- Company Name
- MOOR INSTRUMENTS LIMITED
- Labeler DUNS
- 398037580
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-13
- Public Version
- 1
- Public Version Date
- 2019-01-14
- Public Version Status
- New
- Public Device Record Key
- 92737e0e-1d1d-4445-88bb-e8f2234315cb
Device Description
Non-sterile Oxygenation, and Laser Doppler combined Probes
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 |
|---|---|---|---|---|
| MUD | Oximeter, Tissue Saturation | Cardiovascular | 870.2700 | 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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15060484490140 | GS1 |
Customer Contacts
- Phone
- +44129735715
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K112826 | 000 |