Catalog Number

12370-02

Brand Name

pjur Basic Water

Version/Model Number

pjur Basic Water 100 ml - USA

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K010199,K010199,K010199

Product Code

NUC

Product Code Name

Lubricant, Personal

Public Device Record Key

2d19e208-87ff-4230-8c46-5259c0f74195

Public Version Date

August 31, 2022

Public Version Number

6

DI Record Publish Date

May 01, 2017

Package DI Number

40827160112088

Quantity per Package

12

Contains DI Package

10827160112087

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case