Catalog Number

-

Brand Name

Rymed

Version/Model Number

RYM-8001CL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

6a654c9e-a495-40c3-8201-2ee4103db212

Public Version Date

May 19, 2020

Public Version Number

3

DI Record Publish Date

April 25, 2018

Package DI Number

20817903010609

Quantity per Package

5

Contains DI Package

10817903010602

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case