Catalog Number

-

Brand Name

DOSI-PAIN

Version/Model Number

L25915-250D1-SM

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

097c560e-29f8-473a-a14b-fccc788376d3

Public Version Date

January 31, 2019

Public Version Number

1

DI Record Publish Date

December 31, 2018

Package DI Number

18436020766456

Quantity per Package

10

Contains DI Package

08436020766459

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box