Duns Number:151772415
Device Description: Elite series pillow speakers followed by any alphanumeric characters denoting low energy c Elite series pillow speakers followed by any alphanumeric characters denoting low energy circuitry difference and cable length.
Catalog Number
-
Brand Name
Elite Pillowspeaker
Version/Model Number
XT53CCEIXXXXTAAYL
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
6220e5ea-5941-4c25-ad61-1e432c485d8a
Public Version Date
October 05, 2021
Public Version Number
1
DI Record Publish Date
September 27, 2021
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 |