Catalog Number

DBAG600

Brand Name

Drainage Bag

Version/Model Number

DBAG600

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

K980005,K980005

Product Code

EXF

Product Code Name

Bag, Bile Collecting

Public Device Record Key

00bac574-5ef3-4cd8-9285-f1aeb14d25b7

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 09, 2016

Package DI Number

20886333001426

Quantity per Package

20

Contains DI Package

00886333001422

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box