Catalog Number

-

Brand Name

Day Set III HP

Version/Model Number

640460

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

-

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

K151048,K151048

Product Code

IZQ

Product Code Name

Injector, Contrast Medium, Automatic

Public Device Record Key

613e92e1-7720-4b49-a230-9952672e7c6b

Public Version Date

January 24, 2022

Public Version Number

1

DI Record Publish Date

January 14, 2022

Package DI Number

37630039301881

Quantity per Package

15

Contains DI Package

17630039301887

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton