Catalog Number

105762

Brand Name

NA

Version/Model Number

6432470A

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

54f21eed-a136-473a-b988-7be328cbe5ee

Public Version Date

October 11, 2022

Public Version Number

6

DI Record Publish Date

May 06, 2016

Package DI Number

37332414048915

Quantity per Package

25

Contains DI Package

07332414048914

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE