Catalog Number

ACC010276B

Brand Name

Medline Industries, Inc.

Version/Model Number

ACC010276B

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"

-

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

K003225,K003225

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

dbc05004-a513-4a7a-9cdb-c6e9f25e055c

Public Version Date

June 17, 2022

Public Version Number

4

DI Record Publish Date

August 25, 2019

Package DI Number

40193489777773

Quantity per Package

6

Contains DI Package

10193489777772

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE