Catalog Number

M77460033

Brand Name

Secondary Line

Version/Model Number

SL20 FX-ND

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

7011c926-d662-44d7-9ef3-81dc7ed8cb82

Public Version Date

September 09, 2022

Public Version Number

1

DI Record Publish Date

September 01, 2022

Package DI Number

04250273717655

Quantity per Package

50

Contains DI Package

04250273738421

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box