Catalog Number

-

Brand Name

FLOW-EZE VENTED NEEDLE

Version/Model Number

19B

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K853212,K853212

Product Code

LHI

Product Code Name

Set, I.V. Fluid Transfer

Public Device Record Key

1b06cc5b-ac0c-449d-9159-61bc59ef2d5b

Public Version Date

August 26, 2022

Public Version Number

1

DI Record Publish Date

August 18, 2022

Package DI Number

10810080610030

Quantity per Package

100

Contains DI Package

00810080610033

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case