Identity
- Trade Name
- HET FDA UDI
- Generic Name
- Electrosurgical system monitor/alarm FDA UDI
- Device Name
- Temperature Monitor FDA UDI
- Model / Reference
- 180-1007 FDA UDI
- Description
- Temperature Monitor FDA UDI
Identifiers
- Catalog Number
- 180-1007 FDA UDI
- Primary DI / UDI-DI
- 10884521511156 FDA UDI
- 510(k) Number
- K140422 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Electrosurgical system monitor/alarm FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dry Heat Sterilization FDA UDI
Category: Electrosurgical system monitor/alarm
Het by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrosurgical system monitor/alarm.
- HET — Covidien LP · Class II
Cleared under the same submission
K140422 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
- Covidien LP
Sources (1)
- FDA UDI f413e69e-9cc4-46b4-b1b9-20d3f399264b 37 fields · synced May 30, 2026