Catalog Number

-

Brand Name

Durable Cuff

Version/Model Number

98-0599-5K

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K051904,K051904

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

91e34e7c-349c-4a8e-8401-2078f16938e8

Public Version Date

July 22, 2019

Public Version Number

2

DI Record Publish Date

November 30, 2018

Package DI Number

20840935108105

Quantity per Package

5

Contains DI Package

10840935108108

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box