Slight Touch - Automatic Arm Blood Pressure Monitor Large Cuff - NOBEL SUPPLIES GROUP LLC

Duns Number:069233103

Device Description: Automatic Arm Blood Pressure Monitor Large Cuff

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More Product Details

Catalog Number

-

Brand Name

Slight Touch

Version/Model Number

St-402

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

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Device Record Status

Public Device Record Key

b53f035e-fcf6-4f70-a2c7-5ff6cb32ec48

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 09, 2016

Additional Identifiers

Package DI Number

10862478000329

Quantity per Package

24

Contains DI Package

00862478000322

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"NOBEL SUPPLIES GROUP LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2