Identity
- Trade Name
- Panda iRes Warmer EUDAMEDPanda FDA UDI
- Generic Name
- Infant warmer FDA UDI
- Device Name
- PANDA IRES WARMER EUDAMEDFDA UDI
- Model / Reference
- M1112198 EUDAMEDiRes Warmer FDA UDI
- Description
- PANDA IRES WARMER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682103893 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00390HN EUDAMED
- Direct Marketing DI
- 00840682152716 EUDAMED
- FDA Product Code
- FMT FDA UDI
- EMDN Code
- Z12080407 NEONATAL RADIANT WARMERS EUDAMED
- GMDN Term
- Infant warmer FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5130 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Infant warmer
Panda by Datex-Ohmeda Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Infant warmer.
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- HEATER — RPI · Class II
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- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class II
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- Olympic Warm-Lamps — Natus Medical Incorporated · Class II
- HEATING ELEMENT 741W-120V — RPI · Class II
Cleared under the same submission
K101804 also covers:
K123309 also covers:
K201628 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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
- Datex-Ohmeda Inc.
Sources (2)
- FDA UDI d4ed1c50-ac67-40cc-9b91-909238d8b8e0 35 fields · synced Jul 16, 2026
- EUDAMED 39fef8e6-ed99-492e-9f14-ba82ca4abd62 61 fields · synced Jul 16, 2026