Catalog Number

-

Brand Name

Careone

Version/Model Number

7W926OFC1

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

-

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

K012203,K012203,K012203

Product Code

NUC

Product Code Name

Lubricant, Personal

Public Device Record Key

d86bf8d4-a94c-48a6-96d0-fa033c448b51

Public Version Date

October 19, 2022

Public Version Number

1

DI Record Publish Date

October 11, 2022

Package DI Number

20041520314301

Quantity per Package

6

Contains DI Package

00041520314307

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner