Catalog Number

17830

Brand Name

Patient Administration Set

Version/Model Number

None

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"

-

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

K913416,K913416

Product Code

IYT

Product Code Name

System, Rebreathing, Radionuclide

Public Device Record Key

2d1c57f6-54e9-4cd0-9d37-6992573a5736

Public Version Date

August 08, 2019

Public Version Number

5

DI Record Publish Date

October 06, 2016

Package DI Number

09340598000022

Quantity per Package

50

Contains DI Package

09340598000015

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton