Catalog Number

I550BF85

Brand Name

Medline Industries, Inc.

Version/Model Number

I550BF85

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

Yes

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

e723d6b0-7f4b-43ad-8809-d4b1e5c94200

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

January 22, 2020

Package DI Number

00653160339789

Quantity per Package

10

Contains DI Package

10653160339786

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE