Excel Digital - XL series pillow speakers followed by any - Crest Healthcare Supply

Duns Number:151772415

Device Description: XL series pillow speakers followed by any alphanumeric characters denoting low energy circ

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More Product Details

Catalog Number

-

Brand Name

Excel Digital

Version/Model Number

XL28YRRSXXXZZZ1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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"

-

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 Details

Product Code

IQA

Product Code Name

System, Environmental Control, Powered

Device Record Status

Public Device Record Key

5bd193d5-b38e-454f-98cd-171afe8aa3ef

Public Version Date

March 22, 2019

Public Version Number

3

DI Record Publish Date

January 25, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CREST HEALTHCARE SUPPLY" Characteristics
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