Identity
- Trade Name
- QFlow 500 Perfusion Probe FDA UDI
- Generic Name
- Patient monitoring system module, intracranial pressure FDA UDI
- Device Name
- Thermal Diffusion Probe FDA UDI
- Model / Reference
- NA FDA UDI
- Description
- Thermal Diffusion Probe FDA UDI
Identifiers
- Catalog Number
- H0000-1600 FDA UDI
- Primary DI / UDI-DI
- B238H000016000 FDA UDI
- 510(k) Number
- K013376 FDA UDI
- FDA Product Code
- DPW FDA UDI
- GMDN Term
- Patient monitoring system module, intracranial pressure FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
MR Unsafe FDA UDI
Category: Patient monitoring system module, intracranial pressure
QFlow 500 Perfusion Probe by Hemedex, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K013376 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
- Hemedex, Inc
Sources (1)
- FDA UDI 786891c5-b814-4095-b6f9-f42343660934 35 fields · synced May 31, 2026