Catalog Number

0502-100-000

Brand Name

Fluid Safe

Version/Model Number

0502100000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 02, 2016

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

KDQ

Product Code Name

BOTTLE, COLLECTION, VACUUM

Public Device Record Key

291cfb0a-3365-4529-96da-b952beb8624c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Package DI Number

37613327055291

Quantity per Package

36

Contains DI Package

07613327055290

Package Discontinue Date

December 02, 2016

Package Status

Not in Commercial Distribution

Package Type

pack