Catalog Number

-

Brand Name

SMARTeZ Fluid Transfer Set

Version/Model Number

470020

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

-

Product Code

KYX

Product Code Name

Dispenser, Liquid Medication

Public Device Record Key

679a4572-0a57-4280-af3d-f162eafa64da

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

December 08, 2020

Package DI Number

78859299180020

Quantity per Package

50

Contains DI Package

18859299180028

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton