Identity
- Trade Name
- Panda FDA UDI
- Generic Name
- Infant warmer FDA UDI
- Model / Reference
- i-Res Warmer 1.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682152709 FDA UDI
- FDA Product Code
- FMT FDA UDI
- GMDN Term
- Infant warmer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5130 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Infant warmer
Panda by Datex-Ohmeda Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Infant warmer.
- HEATING ELEMENT 350W-120V — RPI · Class II
- HEATING ELEMENT 440W-104V — RPI · Class II
- HEATER — RPI · Class II
- ADVANCED INFANT WARMER — ADVANCED INSTRUMENTATIONS, INC. · Class II
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class II
- NuBorne Infant Warmer — INTERNATIONAL BIOMEDICAL, LTD. · Class II
- Olympic Warm-Lamps — Natus Medical Incorporated · Class II
- HEATING ELEMENT 741W-120V — RPI · Class II
Cleared under the same submission
K122267 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Datex-Ohmeda Inc.
Sources (1)
- FDA UDI 8c49c74f-6ca8-45cc-acfb-e40856aa308b 34 fields · synced Jun 8, 2026