Catalog Number

CN3255

Brand Name

CAINA

Version/Model Number

325502

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

K193526,K193526,K193526

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

568a5381-776b-4434-8aee-138c95c2f99e

Public Version Date

December 09, 2020

Public Version Number

1

DI Record Publish Date

December 01, 2020

Package DI Number

16971564465158

Quantity per Package

100

Contains DI Package

06971564465151

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-