MedSource Blood Pressure Unit, Pediatric - Blood Pressure Unit, Pediatric - MEDSOURCE INTERNATIONAL LLC

Duns Number:041674552

Device Description: Blood Pressure Unit, Pediatric

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More Product Details

Catalog Number

-

Brand Name

MedSource Blood Pressure Unit, Pediatric

Version/Model Number

MS-BP300

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

39baeca9-ceab-4847-8e59-08d0f2b3b92a

Public Version Date

September 07, 2022

Public Version Number

3

DI Record Publish Date

June 30, 2016

Additional Identifiers

Package DI Number

00840155413481

Quantity per Package

50

Contains DI Package

00816703021491

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"MEDSOURCE INTERNATIONAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 498
2 A medical device with a moderate to high risk that requires special controls. 90