ASSURE Patient Application - ASSURE patient app is a component of CareStation. - Kestra Medical Technologies, Inc.

Duns Number:060944361

Device Description: ASSURE patient app is a component of CareStation.

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More Product Details

Catalog Number

80429-003

Brand Name

ASSURE Patient Application

Version/Model Number

80429-003

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

OUG

Product Code Name

Medical Device Data System

Device Record Status

Public Device Record Key

a10b927d-dade-4826-bcfa-47f40b187af6

Public Version Date

July 04, 2022

Public Version Number

1

DI Record Publish Date

June 24, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KESTRA MEDICAL TECHNOLOGIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
3 A medical device with high risk that requires premarket approval 21