Catalog Number

-

Brand Name

Rymed

Version/Model Number

RYM-5107

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

Yes

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

caa54155-2cf1-4097-a7f6-28512e1426d5

Public Version Date

May 19, 2020

Public Version Number

4

DI Record Publish Date

September 26, 2016

Package DI Number

20817903010159

Quantity per Package

4

Contains DI Package

10817903010152

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case