Duns Number:151772415
Device Description: XT series pillow speakers followed by any alphanumeric characters denoting low energy circ XT series pillow speakers followed by any alphanumeric characters denoting low energy circuitry difference and cable length. For use with WestCom nurse call systems.
Catalog Number
-
Brand Name
Elite Infrared
Version/Model Number
XTW01CEIXXXXTAAYL
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IQA
Product Code Name
System, Environmental Control, Powered
Public Device Record Key
2cd497a7-4b59-4f67-ad62-292b96dbbb1b
Public Version Date
March 22, 2019
Public Version Number
3
DI Record Publish Date
January 25, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 792 |