Catalog Number

-

Brand Name

SHOPKO

Version/Model Number

DBP1332

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 25, 2020

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

734ca4a7-f83f-495a-8f6d-6bb183e09a18

Public Version Date

September 28, 2020

Public Version Number

4

DI Record Publish Date

January 30, 2019

Package DI Number

10400190270776

Quantity per Package

4

Contains DI Package

30400190270770

Package Discontinue Date

September 25, 2020

Package Status

Not in Commercial Distribution

Package Type

-