Catalog Number

600-D

Brand Name

Drainage Bag

Version/Model Number

600-D

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

EXF

Product Code Name

BAG, BILE COLLECTING

Public Device Record Key

722ddbdd-64e1-4b38-bdcd-2c3622950e0a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 21, 2016

Package DI Number

20813079020008

Quantity per Package

20

Contains DI Package

10813079020001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipping Carton