Catalog Number

MSCLEO6

Brand Name

MedStream

Version/Model Number

MSCLEO6

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

02d55bae-eea8-4b94-b265-f7ba6e48381a

Public Version Date

October 06, 2020

Public Version Number

2

DI Record Publish Date

February 28, 2020

Package DI Number

10842472107026

Quantity per Package

50

Contains DI Package

00842472107029

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-