Catalog Number

-

Brand Name

MEDFUSION

Version/Model Number

4000-0107-00

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K111386

Product Code

FRN

Product Code Name

Pump, infusion

Public Device Record Key

894137b4-f74f-4524-b87d-d056f031307b

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

September 18, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-