Catalog Number

-

Brand Name

Portex

Version/Model Number

C45101816D-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

46e1c067-da68-4027-af7c-9f992e40c061

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

June 12, 2020

Package DI Number

35019517223334

Quantity per Package

20

Contains DI Package

15019517223330

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag