Catalog Number

-

Brand Name

Blood Pressure Cuff

Version/Model Number

80031AL

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

K143728

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

2f341cd4-eb72-4c16-934f-142dd95a0dd8

Public Version Date

March 29, 2021

Public Version Number

4

DI Record Publish Date

May 15, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-