Catalog Number

CM-0020

Brand Name

SmartTap™ Paracentesis Drainage Bag, 4L

Version/Model Number

3.8

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EYZ

Product Code Name

System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile

Public Device Record Key

957884e8-93a5-475c-840b-7ad7fdcc0340

Public Version Date

December 07, 2020

Public Version Number

1

DI Record Publish Date

November 27, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-