Catalog Number

-

Brand Name

PiSA BioPharm

Version/Model Number

60009

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

-

Product Code

KPE

Product Code Name

Container, I.V.

Public Device Record Key

f81cd75c-af5f-47e6-a6ea-b52db669662d

Public Version Date

January 20, 2020

Public Version Number

1

DI Record Publish Date

January 10, 2020

Package DI Number

00850002046311

Quantity per Package

50

Contains DI Package

00850002046304

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case