Catalog Number

930101

Brand Name

Kroger

Version/Model Number

930101

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

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

FMK

Product Code Name

Lancet, Blood

Public Device Record Key

0d38bed2-8bb8-4d34-86c8-a620562fb905

Public Version Date

December 09, 2019

Public Version Number

1

DI Record Publish Date

December 01, 2019

Package DI Number

MHC19301013

Quantity per Package

10

Contains DI Package

MHC19301012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case