Catalog Number

S-0500

Brand Name

PLEUR-EVAC

Version/Model Number

IPN025419

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

KDQ

Product Code Name

BOTTLE, COLLECTION, VACUUM

Public Device Record Key

f031076e-44d8-4867-a5d4-63658531e5a0

Public Version Date

August 09, 2018

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

44026704451713

Quantity per Package

6

Contains DI Package

34026704451716

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case