Catalog Number

107650

Brand Name

NA

Version/Model Number

6033765

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

MON

Product Code Name

SYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES

Public Device Record Key

c28c6df6-bb6c-4928-ab9b-aff64e2385dd

Public Version Date

October 11, 2022

Public Version Number

2

DI Record Publish Date

July 30, 2021

Package DI Number

37332414075829

Quantity per Package

30

Contains DI Package

07332414075828

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE