Catalog Number

105551

Brand Name

NA

Version/Model Number

6032205

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

K823707,K823707

Product Code

KOC

Product Code Name

ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Public Device Record Key

77c6a558-d131-42cc-820c-366f82278a9e

Public Version Date

June 07, 2019

Public Version Number

4

DI Record Publish Date

May 31, 2017

Package DI Number

37332414044733

Quantity per Package

50

Contains DI Package

07332414044732

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE