Catalog Number

515079

Brand Name

BD PhaSeal Optima

Version/Model Number

515079

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"

-

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

ONB

Product Code Name

Closed antineoplastic and hazardous drug reconstitution and transfer system

Public Device Record Key

0714869e-48c8-4872-aec2-a8c5704d6933

Public Version Date

July 23, 2021

Public Version Number

1

DI Record Publish Date

July 15, 2021

Package DI Number

50382905150796

Quantity per Package

250

Contains DI Package

00382905150791

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case