Catalog Number

-

Brand Name

TDOC Air-Charged 7Fr Triple Lumen, Dual Sensor Bladder Catheter

Version/Model Number

CATT3B37

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

FEN

Product Code Name

Device, Cystometric, Hydraulic

Public Device Record Key

b4f1bee9-451b-473f-bb3f-32f42da4ba70

Public Version Date

September 05, 2019

Public Version Number

1

DI Record Publish Date

August 28, 2019

Package DI Number

10627825011157

Quantity per Package

10

Contains DI Package

00627825011150

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-