Catalog Number

406XL

Brand Name

Advocate Blood Pressure Monitor Model SPBP-04 Upper Arm XL Cuff

Version/Model Number

406XL

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K150430,K150430,K150430

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

c565506b-93eb-4bc2-be38-2bac5d200e91

Public Version Date

November 09, 2020

Public Version Number

7

DI Record Publish Date

August 22, 2016

Package DI Number

10894046001537

Quantity per Package

3

Contains DI Package

00894046001530

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

406XL-I