Catalog Number

0465348

Brand Name

Hospira

Version/Model Number

465348

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

JOL

Product Code Name

CATHETER AND TIP, SUCTION

Public Device Record Key

158153d8-3072-46a4-a7c2-5e7e6beeab2e

Public Version Date

July 23, 2020

Public Version Number

4

DI Record Publish Date

September 01, 2016

Package DI Number

20887787006647

Quantity per Package

48

Contains DI Package

10887787006640

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case