Catalog Number

308.082

Brand Name

AccuPort® Cannula

Version/Model Number

308.082

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

K190814

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

6bd28b31-ee00-460b-a886-a2fd08d79f50

Public Version Date

October 18, 2022

Public Version Number

4

DI Record Publish Date

May 18, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-