Catalog Number

350-8400

Brand Name

Aseptic Fluid Transfer Set

Version/Model Number

350-8400

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

K780417,K780417

Product Code

GAZ

Product Code Name

TUBING, NONINVASIVE

Public Device Record Key

40ddf44d-9014-48f5-b120-bdc5145a6196

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

10081317024948

Quantity per Package

4

Contains DI Package

00081317024941

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box