Catalog Number

-

Brand Name

Custom Healthcare Systems Inc.

Version/Model Number

D36-9686

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

KIT

Product Code Name

Media And Components, Synthetic Cell And Tissue Culture

Public Device Record Key

0b6ae64a-22fc-41e1-b1f3-e0ff4737fefe

Public Version Date

September 24, 2018

Public Version Number

2

DI Record Publish Date

July 30, 2018

Package DI Number

20811870031827

Quantity per Package

25

Contains DI Package

00811870031823

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

N/A