FDA UDI
In Commercial Distribution
🇺🇸 United States
ShuntCheck III Software
DI: 00865435000311
·
Model: SCIII SW
·
NEURODX DEVELOPMENT LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ShuntCheck III Software
- Primary DI
- 00865435000311
- Version / Model
- SCIII SW
- Catalog Number
- SCIII SW
- Company Name
- NEURODX DEVELOPMENT LLC
- Labeler DUNS
- 828682240
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-18
- Public Version
- 1
- Public Version Date
- 2018-11-19
- Public Version Status
- New
- Public Device Record Key
- d7a175c0-f51f-41ef-bfc7-c8dd9fd38458
Device Description
ShuntCheck software - Installed on Windows computer; guides user through test procedure, gathers and analyzes thermal data, presents results screen with Flow Confirmed or Flow Not Confirmed plus a time-temperature graph
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
- 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 |
|---|---|---|---|---|
| JXG | Shunt, Central Nervous System And Components | Neurology | 882.5550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60309 | Heater/cooler system tester kit | A collection of devices intended to be used to test/calibrate a clinical heater/cooler system (e.g., extravascular-circulation hyperthermia system, heating/cooling pad systems) with respect to fluid flow, thermal calibration, and electronic integrity. The kit may include a pressure/flow calibration unit, a thermocouple thermometer, a breakout box and relevant connection cables. It is intended to be used by a healthcare provider (i.e., clinical technician) in a clinical setting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00865435000311 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123554 | 000 |