Catalog Number

-

Brand Name

Rymed

Version/Model Number

RYM-3107F2

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

a5751c5a-e235-4b82-856a-ca80a2058fd0

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 25, 2019

Package DI Number

20817903010814

Quantity per Package

4

Contains DI Package

10817903010817

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case