Identity
- Trade Name
- Olympic Warm-Lamps FDA UDI
- Generic Name
- Infant warmer FDA UDI
- Device Name
- "The Olympic Warm-Lamp Model 31 is a source of controllable heat in the patient care environment. It provides extra warmth for infant patients when out of the bassinet for examination, bathing, weighing, feeding, or minor procedures. Adult and pediatric patients during routine procedures and examinations. Objects patients contact, such as scales, tables, and blankets. The distance measurer (retractable tape) mounted on the head assembly allows you to confirm a safe minimum distance from the heat source, while the intensity control allows you to set just the right level of radiant heat. feeding, or minor procedures." FDA UDI
- Model / Reference
- Model 31 FDA UDI
- Description
- "The Olympic Warm-Lamp Model 31 is a source of controllable heat in the patient care environment. It provides extra warmth for infant patients when out of the bassinet for examination, bathing, weighing, feeding, or minor procedures. Adult and pediatric patients during routine procedures and examinations. Objects patients contact, such as scales, tables, and blankets. The distance measurer (retractable tape) mounted on the head assembly allows you to confirm a safe minimum distance from the heat source, while the intensity control allows you to set just the right level of radiant heat. feeding, or minor procedures." FDA UDI
Identifiers
- Catalog Number
- 56831 FDA UDI
- Primary DI / UDI-DI
- 00382830005463 FDA UDI
- 510(k) Number
- K932881 FDA UDI
- FDA Product Code
- ILY FDA UDI
- GMDN Term
- Infant warmer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5500 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
No
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
Olympic Warm-Lamps by Natus Medical Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K932881 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
- Natus Medical Incorporated
Sources (1)
- FDA UDI 11bcab82-932f-40c7-875f-b94bd9a587d4 37 fields · synced Jun 8, 2026