Catalog Number

ASK-41541-SH

Brand Name

ARROW

Version/Model Number

IPN038357

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

PND

Product Code Name

Midline catheter

Public Device Record Key

62d114da-00f8-4ae6-891c-f6553527153a

Public Version Date

June 07, 2019

Public Version Number

4

DI Record Publish Date

February 12, 2018

Package DI Number

20801902139348

Quantity per Package

5

Contains DI Package

10801902139341

Package Discontinue Date

January 04, 2019

Package Status

Not in Commercial Distribution

Package Type

Case