Catalog Number

-

Brand Name

crn CRONO Syringe reservoir

Version/Model Number

CRN/20/WN

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

K041414,K041414,K041414

Product Code

FRN

Product Code Name

Pump, Infusion

Public Device Record Key

21f6234d-af52-455d-8fc7-595fa707d700

Public Version Date

September 12, 2018

Public Version Number

4

DI Record Publish Date

April 11, 2017

Package DI Number

28050616611530

Quantity per Package

4

Contains DI Package

18050616611533

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box