Catalog Number

-

Brand Name

Care Touch

Version/Model Number

IC

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

-

Product Code

QRL

Product Code Name

Multiple Use Blood Lancet For Single Patient Use Only

Public Device Record Key

d3955918-9be7-4892-a013-2d7375f3c389

Public Version Date

July 18, 2022

Public Version Number

1

DI Record Publish Date

July 08, 2022

Package DI Number

20810011730230

Quantity per Package

2000

Contains DI Package

10810011730233

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

inner case