Catalog Number

-

Brand Name

MEDFUSION

Version/Model Number

67-2450-010700-01

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)

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

379b963c-7f50-45d6-b6ac-de96aeee762d

Public Version Date

January 22, 2020

Public Version Number

2

DI Record Publish Date

September 20, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-