Catalog Number

515305

Brand Name

BD PhaSeal

Version/Model Number

515305

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

617edfd3-ea34-436e-9fcf-7565d1b14736

Public Version Date

November 22, 2018

Public Version Number

1

DI Record Publish Date

October 22, 2018

Package DI Number

30382905153052

Quantity per Package

50

Contains DI Package

00382905153051

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelfpack