DECT Telephone Home Communicator - Kit Handset/Base DT1000A, Home Communicator - Lifeline Systems Company

Duns Number:080030042

Device Description: Kit Handset/Base DT1000A, Home Communicator

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More Product Details

Catalog Number

DTBS1000A

Brand Name

DECT Telephone Home Communicator

Version/Model Number

1890109

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)

Yes

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

d66c049c-c935-47c4-a90f-b517b9224536

Public Version Date

October 19, 2021

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LIFELINE SYSTEMS COMPANY" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 92