Catalog Number

-

Brand Name

SMARTeZ Pump

Version/Model Number

480101

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

a6d7091d-8f7a-4d3e-a4b9-d667180a2202

Public Version Date

March 12, 2020

Public Version Number

1

DI Record Publish Date

March 04, 2020

Package DI Number

48859299100102

Quantity per Package

12

Contains DI Package

18859299100101

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton