Catalog Number

PDC-36

Brand Name

Drainage Bag

Version/Model Number

PDC-36

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

EXF

Product Code Name

Bag, Bile Collecting

Public Device Record Key

a1349c4a-676d-4182-948b-2097b02e39b4

Public Version Date

June 13, 2022

Public Version Number

1

DI Record Publish Date

June 03, 2022

Package DI Number

20817640020473

Quantity per Package

75

Contains DI Package

00817640020479

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper