Catalog Number

-

Brand Name

NovaLine

Version/Model Number

BL 12

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FJK

Product Code Name

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Public Device Record Key

934c4dd7-8511-4028-b489-0504177bc686

Public Version Date

March 23, 2021

Public Version Number

1

DI Record Publish Date

March 15, 2021

Package DI Number

16948082702119

Quantity per Package

24

Contains DI Package

06948082702112

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-