Catalog Number

515001

Brand Name

BD PhaSeal

Version/Model Number

515001

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

c8d804e4-0a13-4606-b9d6-59b261a34d3e

Public Version Date

October 23, 2019

Public Version Number

3

DI Record Publish Date

September 19, 2016

Package DI Number

50382905150017

Quantity per Package

4

Contains DI Package

30382905150013

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case