Care Touch - Digital Wrist Blood Pressure Monitor - FUTURE DIAGNOSTICS LLC

Duns Number:080113296

Device Description: Digital Wrist Blood Pressure Monitor

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More Product Details

Catalog Number

-

Brand Name

Care Touch

Version/Model Number

CTCSW

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"

Yes

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

K131463,K131463

Product Code Details

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Device Record Status

Public Device Record Key

86e3fd62-f3e2-4586-bb6b-7da4fdb8be73

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 27, 2016

Additional Identifiers

Package DI Number

10370393904016

Quantity per Package

40

Contains DI Package

00370393904019

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"FUTURE DIAGNOSTICS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 5