Catalog Number

-

Brand Name

PremierPro

Version/Model Number

6101

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"

Yes

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

K092245,K092245

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

e3a57895-7613-4fce-b134-9b292ec2e44a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 01, 2016

Package DI Number

10818566012897

Quantity per Package

24

Contains DI Package

00818566012890

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case