Catalog Number

-

Brand Name

SMARTeZ Pump

Version/Model Number

481071

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

b6e14e59-7fcb-480b-9ab7-8c15ff81f181

Public Version Date

March 12, 2020

Public Version Number

1

DI Record Publish Date

March 04, 2020

Package DI Number

58859299101076

Quantity per Package

12

Contains DI Package

28859299101075

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton