Catalog Number

GW2535I

Brand Name

MEDLINE

Version/Model Number

GW2535I

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

-

Product Code

OFD

Product Code Name

Catheter introducer kit

Public Device Record Key

27bf6d21-6582-469a-b1fd-6cc528d1e38a

Public Version Date

December 24, 2021

Public Version Number

1

DI Record Publish Date

December 16, 2021

Package DI Number

10653160349501

Quantity per Package

10

Contains DI Package

20653160349508

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE