Catalog Number

-

Brand Name

Custom Healthcare Systems Inc.

Version/Model Number

B9-8369B

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

-

Product Code Name

-

Public Device Record Key

c73abfca-3fa7-46ac-aad0-ed1dfd747e8f

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

July 26, 2018

Package DI Number

20811870030097

Quantity per Package

12

Contains DI Package

00811870030093

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

N/A