Catalog Number

515065

Brand Name

BD PhaSeal Optima

Version/Model Number

515065

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

81dc7e26-6c3e-41f2-a80b-a91ac63d9594

Public Version Date

November 15, 2021

Public Version Number

1

DI Record Publish Date

November 05, 2021

Package DI Number

50382905150659

Quantity per Package

150

Contains DI Package

00382905150654

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case