Catalog Number

SN01001

Brand Name

CAINA

Version/Model Number

1ML LL

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

K192551,K192551,K192551

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

df04c2d6-810c-4262-865d-78b9a9887e8a

Public Version Date

February 15, 2021

Public Version Number

1

DI Record Publish Date

February 05, 2021

Package DI Number

16971564465264

Quantity per Package

100

Contains DI Package

06971564465267

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-