ThermoTrace Core (5pcs)
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- ThermoTrace, zentral, (5 Stk.) EUDAMEDThermoTrace Core (5pcs) FDA UDI
- Generic Name
- General-purpose patient temperature probe, single-use FDA UDI
- Model / Reference
- MX11000 EUDAMEDFDA UDI1080506K19Z000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675428916 EUDAMEDFDA UDI
- Basic UDI-DI
- 0404867511080506K19Z000QY EUDAMED
- 510(k) Number
- K971198 FDA UDI
- FDA Product Code
- FMT FDA UDI
- EMDN Code
- V03010201 TEMPERATURE MONITORING CUTANEOUS PROBES EUDAMED
- GMDN Term
- General-purpose patient temperature probe, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5130 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: General-purpose patient temperature probe, single-use
ThermoTrace Core (5pcs) by Drägerwerk AG & Co. KGaA — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K971198 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Drägerwerk AG & Co. KGaA
Sources (2)
- FDA UDI 54a82841-7b67-451a-8afb-2528a1a41c31 34 fields · synced Jun 19, 2026
- EUDAMED e1d8cae7-a0d6-44e1-b70a-9e2f932df6e3 61 fields · synced Jun 19, 2026