Catalog Number

7001-3915

Brand Name

SaniGuard

Version/Model Number

7001-3915

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

K852605,K852605,K852605

Product Code

FJK

Product Code Name

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Public Device Record Key

5946582d-13ab-487a-bc1d-82821bdedf67

Public Version Date

September 09, 2020

Public Version Number

5

DI Record Publish Date

January 19, 2017

Package DI Number

20858293006025

Quantity per Package

2000

Contains DI Package

00858293006021

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

package