Catalog Number

-

Brand Name

Portex

Version/Model Number

101/870/070CZ

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K173384,K173384,K173384

Product Code

BTC

Product Code Name

BAG, RESERVOIR

Public Device Record Key

a17782d9-0bee-4138-9b6b-35ee0df5768d

Public Version Date

June 05, 2020

Public Version Number

2

DI Record Publish Date

January 16, 2019

Package DI Number

35019517076206

Quantity per Package

1

Contains DI Package

15019517076202

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box