Catalog Number

DYNDTNBC21GL

Brand Name

Medline

Version/Model Number

DYNDTNBC21GL

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

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

0afff86e-0d2e-46f3-a736-c02ed26ebb44

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

November 25, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-