Catalog Number

1252.31G

Brand Name

Nutriline

Version/Model Number

1252.31G

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

K051690,K051690,K051690

Product Code

LJS

Product Code Name

Catheter, intravascular, therapeutic, long-term greater than 30 days

Public Device Record Key

2b608a96-1429-4bbe-8c79-2c9a8d2727fb

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

March 13, 2020

Package DI Number

50849884000868

Quantity per Package

6

Contains DI Package

30849884000864

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-