Identity
- Trade Name
- Elite Infrared FDA UDI
- Generic Name
- Nurse call system FDA UDI
- Device Name
- XT series pillow speakers followed by any alphanumeric characters denoting low energy circuitry difference and cable length. For use with Universal nurse call systems. FDA UDI
- Model / Reference
- XT44CCEIXXXXTAAYL FDA UDI
- Description
- XT series pillow speakers followed by any alphanumeric characters denoting low energy circuitry difference and cable length. For use with Universal nurse call systems. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B484XT44CCEIXXXXTAAYL0 FDA UDI
- FDA Product Code
- IQA FDA UDI
- GMDN Term
- Nurse call system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.3725 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 8 Feet FDA UDI
Category: Nurse call system
Elite Infrared by Crest Healthcare Supply — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- ASCOM — Ascom Sweden AB · Class II
- Responder — RAULAND-BORG CORPORATION · Class I
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
- Crest Healthcare Supply
Sources (1)
- FDA UDI 1716d80d-985b-4af1-b47c-aaaacb38da47 35 fields · synced Jun 1, 2026