Catalog Number

-

Brand Name

DOSI-FUSER

Version/Model Number

L25915-250H1-FDA

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 09, 2018

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

K040752,K040752

Product Code

MEB

Product Code Name

Pump, Infusion, Elastomeric

Public Device Record Key

0b695f83-c8e6-4005-988c-962a80e784bf

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 31, 2016

Package DI Number

18436020766098

Quantity per Package

10

Contains DI Package

08436020766091

Package Discontinue Date

March 09, 2018

Package Status

Not in Commercial Distribution

Package Type

Box