Catalog Number

DYNDTNBCS23G

Brand Name

Medline

Version/Model Number

DYNDTNBCS23G

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K151991,K151991,K151991

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

80c37e38-3ac6-416f-b820-c7ed73071f09

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

December 01, 2020

Package DI Number

30888277680238

Quantity per Package

200

Contains DI Package

20888277680231

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE