Catalog Number

Not Applicable

Brand Name

MedSource Blood Pressure Cuff Barrier

Version/Model Number

MS-44000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

Yes

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

OEA

Product Code Name

Non-Surgical Isolation Gown

Public Device Record Key

5c04dec6-ef70-4ca1-81cd-26c723757be1

Public Version Date

July 15, 2021

Public Version Number

1

DI Record Publish Date

July 07, 2021

Package DI Number

00840155401310

Quantity per Package

500

Contains DI Package

00840155401303

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case