Catalog Number

-

Brand Name

Meridian Medical

Version/Model Number

#6104M-S

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 25, 2019

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Public Device Record Key

f7991df2-6ed4-4255-b101-ea54f79d8da7

Public Version Date

April 26, 2019

Public Version Number

3

DI Record Publish Date

October 19, 2016

Package DI Number

30815067040125

Quantity per Package

10

Contains DI Package

00815067040124

Package Discontinue Date

April 25, 2019

Package Status

Not in Commercial Distribution

Package Type

CA