Catalog Number

SL-2010M2096

Brand Name

Hemodialysis Bloodlines

Version/Model Number

SL-2010M2096

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"

Yes

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

9bff2f22-67df-48bc-bebe-1d619c5a65fd

Public Version Date

August 17, 2020

Public Version Number

1

DI Record Publish Date

August 07, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-