zuvo - zuvo 10 speech generating device - Talk To ME Technologies, LLC

Duns Number:002607830

Device Description: zuvo 10 speech generating device

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More Product Details

Catalog Number

-

Brand Name

zuvo

Version/Model Number

10

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

ILQ

Product Code Name

System, Communication, Powered

Device Record Status

Public Device Record Key

1950b97d-1644-4c8a-9591-310361598b18

Public Version Date

September 02, 2022

Public Version Number

1

DI Record Publish Date

August 25, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TALK TO ME TECHNOLOGIES, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 12