Catalog Number

-

Brand Name

SMARTeZ Pump

Version/Model Number

481036

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,K151650

Product Code

MEB

Product Code Name

Pump, Infusion, Elastomeric

Public Device Record Key

ab640490-6aac-4458-a7db-066945ae5c2e

Public Version Date

December 03, 2020

Public Version Number

1

DI Record Publish Date

November 25, 2020

Package DI Number

98859299101036

Quantity per Package

48

Contains DI Package

68859299101035

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-