Catalog Number

-

Brand Name

MEDLINE

Version/Model Number

89055NS

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

-

Product Code

FHF

Product Code Name

System, Evacuator, Fluid

Public Device Record Key

c7c840bd-0816-401e-b38f-69692d517f31

Public Version Date

August 21, 2019

Public Version Number

4

DI Record Publish Date

December 16, 2017

Package DI Number

26939029815167

Quantity per Package

4

Contains DI Package

16939029815160

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton