Identity
- Trade Name
- ShuntCheck III Software FDA UDI
- Generic Name
- Heater/cooler system tester kit FDA UDI
- Device Name
- 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 FDA UDI
- Model / Reference
- SCIII SW FDA UDI
- 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 FDA UDI
Identifiers
- Catalog Number
- SCIII SW FDA UDI
- Primary DI / UDI-DI
- 00865435000311 FDA UDI
- 510(k) Number
- K123554 FDA UDI
- FDA Product Code
- JXG FDA UDI
- GMDN Term
- Heater/cooler system tester kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5550 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Heater/cooler system tester kit
ShuntCheck III Software by Neurodx Development, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Heater/cooler system tester kit.
- CADD — ICU MEDICAL, INC. · Class II
- MDHC — MDHC Life Technologies (Kunshan) Co., LTD. · Class I
- ShuntCheck III DAQ — Neurodx Development, LLC · Class II
- ShuntCheck Test Pack — Neurodx Development, LLC · Class II
Cleared under the same submission
K123554 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Neurodx Development, LLC
Sources (1)
- FDA UDI d7a175c0-f51f-41ef-bfc7-c8dd9fd38458 35 fields · synced May 30, 2026