Catalog Number

-

Brand Name

Portex

Version/Model Number

C1046J

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)

Yes

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

BTC

Product Code Name

BAG, RESERVOIR

Public Device Record Key

657b496b-64d1-4193-8f26-59a741bc2b07

Public Version Date

October 24, 2022

Public Version Number

4

DI Record Publish Date

October 05, 2016

Package DI Number

30351688434221

Quantity per Package

15

Contains DI Package

10351688434227

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON