Catalog Number

M77460026

Brand Name

Secondary Line

Version/Model Number

SL FX

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K121613,K121613

Product Code

FRN

Product Code Name

Pump, Infusion

Public Device Record Key

10dc31cb-c18b-4f85-bdcd-a3cb06e49370

Public Version Date

September 09, 2022

Public Version Number

1

DI Record Publish Date

September 01, 2022

Package DI Number

04250273713626

Quantity per Package

40

Contains DI Package

04250273735222

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box