Catalog Number

BUC06P

Brand Name

BD Intermittent

Version/Model Number

BUC06P

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

K111405,K111405,K111405

Product Code

GBM

Product Code Name

Catheter, Urethral

Public Device Record Key

c2828745-cb66-4601-af9e-9970b6d35bbc

Public Version Date

October 19, 2020

Public Version Number

1

DI Record Publish Date

October 09, 2020

Package DI Number

16948796203896

Quantity per Package

30

Contains DI Package

06948796203899

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA