Catalog Number

-

Brand Name

Rymed

Version/Model Number

RYM-5315

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

Yes

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

K991653,K991653,K991653

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

99c347c6-1d50-44f0-88c5-70b0c06a4402

Public Version Date

May 19, 2020

Public Version Number

3

DI Record Publish Date

April 25, 2018

Package DI Number

20817903010395

Quantity per Package

4

Contains DI Package

10817903010398

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case