Catalog Number

SF5060

Brand Name

Springfusor

Version/Model Number

Springfusor 50/60

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K910007,K910007

Product Code

FRN

Product Code Name

Pump, Infusion

Public Device Record Key

c7c8a811-ae7c-468d-b5dd-aa3b7770bcd4

Public Version Date

June 17, 2022

Public Version Number

4

DI Record Publish Date

May 17, 2017

Package DI Number

09350902001683

Quantity per Package

40

Contains DI Package

09350902001607

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping carton