Catalog Number

-

Brand Name

Portex

Version/Model Number

C4503577-NL

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

BTC

Product Code Name

BAG, RESERVOIR

Public Device Record Key

67b7ce30-0644-4f9e-917c-26d0f0f661d8

Public Version Date

October 24, 2022

Public Version Number

4

DI Record Publish Date

October 05, 2016

Package DI Number

30351688421689

Quantity per Package

12

Contains DI Package

10351688421685

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON