Catalog Number

-

Brand Name

DOSI-FLOW

Version/Model Number

L259000097

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

K851058,K851058

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

43dee9b4-b5d2-412f-b153-7d2168dec135

Public Version Date

June 05, 2020

Public Version Number

4

DI Record Publish Date

November 30, 2016

Package DI Number

18436020760560

Quantity per Package

50

Contains DI Package

08436020760563

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box