Temp Probe Ped 1.5M reusable
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- TEMP.SONDE PÄD. 1,5M, MEHRWEG EUDAMEDTemp Probe Ped 1.5M reusable FDA UDI
- Generic Name
- General-purpose patient temperature probe, reusable FDA UDI
- Model / Reference
- 4329848 EUDAMEDFDA UDI207018VK19Z000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049098009294 EUDAMEDFDA UDI
- Basic UDI-DI
- 040486752207018VK19Z000F9 EUDAMED
- Direct Marketing DI
- 04049098009294 EUDAMED
- FDA Product Code
- FLL FDA UDI
- EMDN Code
- Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- General-purpose patient temperature probe, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.2910 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
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
Yes
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: General-purpose patient temperature probe, reusable
Temp Probe Ped 1.5M reusable by Draeger Medical Systems, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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
- Draeger Medical Systems, Inc.
Sources (2)
- FDA UDI f8376db7-75e9-45d3-8e8b-19473e8dbebf 33 fields · synced Jul 10, 2026
- EUDAMED 1c047248-36e5-4aed-bf88-76a8b058d2f7 61 fields · synced Jul 10, 2026