Paramed - Is a device used to measure blood pressure, - SILEX GLOBAL LLC

Duns Number:081135914

Device Description: Is a device used to measure blood pressure, composed of an inflatable cuff to collapse and Is a device used to measure blood pressure, composed of an inflatable cuff to collapse and then release the artery under the cuff in a controlled manner, and a mechanical manometer to measure the pressure.

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More Product Details

Catalog Number

-

Brand Name

Paramed

Version/Model Number

Manual Blood Pressure cuff (Pink Color). Comfort Model

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

DXQ

Product Code Name

Blood Pressure Cuff

Device Record Status

Public Device Record Key

999db56b-9948-418f-9439-f5fadbb3dd0f

Public Version Date

June 18, 2018

Public Version Number

1

DI Record Publish Date

May 18, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SILEX GLOBAL LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 30