Catalog Number

-

Brand Name

UNBRANDED

Version/Model Number

HP48RNS

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DTL

Product Code Name

Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass

Public Device Record Key

fe5e81a6-39cd-4636-a55d-350fb4dd7420

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 27, 2016

Package DI Number

10848340006156

Quantity per Package

100

Contains DI Package

00848340006159

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-