Catalog Number

-

Brand Name

Accu-Read

Version/Model Number

BP00-0101

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K171889,K171889,K171889

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

400737d4-d2b9-4e62-a9a1-78cad9254db7

Public Version Date

September 06, 2019

Public Version Number

1

DI Record Publish Date

August 29, 2019

Package DI Number

20858293006414

Quantity per Package

20

Contains DI Package

00858293006410

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag