Catalog Number

-

Brand Name

Portex

Version/Model Number

C45091528-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

6f4ef8b8-b2d0-45ec-bb87-505e3b830b6e

Public Version Date

October 24, 2022

Public Version Number

4

DI Record Publish Date

January 03, 2017

Package DI Number

30351688435747

Quantity per Package

20

Contains DI Package

10351688435743

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON