Catalog Number

S3007-01

Brand Name

TRUEdraw

Version/Model Number

CVS TRUEdraw Lancing Device

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

-

Product Code

FMK

Product Code Name

Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Public Device Record Key

6a102dd2-3ca6-4e85-a6d4-f756de6f2e9f

Public Version Date

January 10, 2022

Public Version Number

1

DI Record Publish Date

December 31, 2021

Package DI Number

10050428645946

Quantity per Package

50

Contains DI Package

00050428645949

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE