Catalog Number

MDE401000

Brand Name

MediFlo

Version/Model Number

MDE401000

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"

Yes

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

K151650,K151650

Product Code

MEB

Product Code Name

Pump, Infusion, Elastomeric

Public Device Record Key

2abc5e40-98ea-4188-8f1f-a337e3371123

Public Version Date

December 01, 2020

Public Version Number

1

DI Record Publish Date

November 23, 2020

Package DI Number

10850007185005

Quantity per Package

24

Contains DI Package

00850007185008

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case