Identity
- Trade Name
- CorTemp FDA UDI
- Generic Name
- Temperature telemetric monitoring system transmitter FDA UDI
- Device Name
- Handheld electronic device which receives temperature sensitive crystal oscillations via near field magnetic link. The oscillation measurement is converted to a temperature using the sensor's calibration number. FDA UDI
- Model / Reference
- HT150001 FDA UDI
- Description
- Handheld electronic device which receives temperature sensitive crystal oscillations via near field magnetic link. The oscillation measurement is converted to a temperature using the sensor's calibration number. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857414006025 FDA UDI
- 510(k) Number
- K880639 FDA UDI
- FDA Product Code
- FLL FDA UDI
- GMDN Term
- Temperature telemetric monitoring system transmitter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.2910 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Temperature telemetric monitoring system transmitter
CorTemp by H Q, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Temperature telemetric monitoring system transmitter.
- VitalSense — Respironics, Inc. · Class II
- VitalSense — Respironics, Inc. · Class II
- CorTemp — H Q, INC · Class II
- CorTemp — H Q, INC · Class II
- CorTemp — H Q, INC · Class II
- CorTemp — H Q, INC · Class II
Cleared under the same submission
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
- H Q, Inc
Sources (1)
- FDA UDI fdbff23e-6b96-47fc-83dc-d499f973cb0d 35 fields · synced Jun 8, 2026