Philips GoSafe - 7100MHB (GoSafe) - Lifeline Systems Company

Duns Number:080030042

Device Description: 7100MHB (GoSafe)

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More Product Details

Catalog Number

7100MHB

Brand Name

Philips GoSafe

Version/Model Number

300000188981

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

9c13a83e-3f30-477a-bd76-22da865ecfd3

Public Version Date

October 19, 2021

Public Version Number

3

DI Record Publish Date

October 23, 2017

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