Catalog Number

-

Brand Name

Meridian Medical

Version/Model Number

#6003L-4

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 01, 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

K974393,K974393

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Public Device Record Key

8cc0d0d8-7f14-4357-bf7b-56fb44360b9e

Public Version Date

August 03, 2020

Public Version Number

4

DI Record Publish Date

February 17, 2017

Package DI Number

30815067043423

Quantity per Package

20

Contains DI Package

00815067043422

Package Discontinue Date

April 01, 2019

Package Status

Not in Commercial Distribution

Package Type

Shipper