Catalog Number

-

Brand Name

SMARTeZ Pump

Version/Model Number

481032

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K151650,K151650

Product Code

MEB

Product Code Name

Pump, Infusion, Elastomeric

Public Device Record Key

4192bb33-762e-46df-a95a-a9430f54058f

Public Version Date

March 12, 2020

Public Version Number

1

DI Record Publish Date

March 04, 2020

Package DI Number

58859299101038

Quantity per Package

24

Contains DI Package

28859299101037

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton