Catalog Number

-

Brand Name

crn CRONO Syringe reservoir

Version/Model Number

CRN50ML

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

Product Code

FRN

Product Code Name

Pump, Infusion

Public Device Record Key

83d9b3c5-76fd-4202-a6c6-e2a4efb132ab

Public Version Date

September 12, 2018

Public Version Number

4

DI Record Publish Date

April 11, 2017

Package DI Number

18050616611557

Quantity per Package

60

Contains DI Package

08050616611550

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box