Catalog Number

-

Brand Name

DOSI-FUSER

Version/Model Number

L25915-500D1-USA

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

K040752,K040752

Product Code

MEB

Product Code Name

Pump, Infusion, Elastomeric

Public Device Record Key

3a0cf51a-d1b7-4849-b930-a01f27ea62a3

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 12, 2017

Package DI Number

18436020767477

Quantity per Package

10

Contains DI Package

08436020767470

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box