Catalog Number

101354

Brand Name

NA

Version/Model Number

6431233B

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

K801016,K801016

Product Code

FJK

Product Code Name

SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Public Device Record Key

fdaade90-24b9-4f0a-9f1f-316058f22795

Public Version Date

June 07, 2019

Public Version Number

4

DI Record Publish Date

October 28, 2016

Package DI Number

37332414004690

Quantity per Package

50

Contains DI Package

07332414004699

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE