Catalog Number

ZZABPCUFF

Brand Name

BodyMed

Version/Model Number

ZZABPCUFF

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

K131558,K131558

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

483002a4-48b5-48d6-b12d-3274f7ac9237

Public Version Date

February 27, 2020

Public Version Number

4

DI Record Publish Date

September 05, 2016

Package DI Number

20815802014469

Quantity per Package

100

Contains DI Package

00815802014465

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master carton