Catalog Number

06-270-191

Brand Name

MABIS

Version/Model Number

06-270-191

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K082542,K082542

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

b5c8ac04-6693-4481-bd8c-a19b2ec7e2f5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 11, 2017

Package DI Number

10767056081069

Quantity per Package

30

Contains DI Package

00767056060180

Package Discontinue Date

-

Package Status

-

Package Type

Master Carton