Catalog Number

LBL2-1430HB

Brand Name

Ulti-Flo General Purpose Drainage Catheter

Version/Model Number

LBL2-1430HB

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"

Yes

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

GBO

Product Code Name

Catheter, Nephrostomy, General & Plastic Surgery

Public Device Record Key

7aa71d29-de6b-411e-bba9-7c9ddb87d19b

Public Version Date

May 06, 2022

Public Version Number

1

DI Record Publish Date

April 28, 2022

Package DI Number

10817640021336

Quantity per Package

5

Contains DI Package

00817640021339

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Dispenser