Catalog Number

-

Brand Name

Sani-lok Blood Port Barrier Adaptor

Version/Model Number

7000-1050

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

-

Product Code

MON

Product Code Name

System, Hemodialysis, Remote Accessories

Public Device Record Key

1757d306-1180-4ea5-a5e9-7eb836649213

Public Version Date

May 21, 2021

Public Version Number

1

DI Record Publish Date

May 13, 2021

Package DI Number

00858293006878

Quantity per Package

200

Contains DI Package

00858293006861

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag