Catalog Number

-

Brand Name

ReliOn

Version/Model Number

HH-XIII-T

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

QRL

Product Code Name

Multiple Use Blood Lancet For Single Patient Use Only

Public Device Record Key

86dfc92c-36fc-4aa6-bd9e-f65bf794671a

Public Version Date

June 07, 2022

Public Version Number

1

DI Record Publish Date

May 30, 2022

Package DI Number

10810011730219

Quantity per Package

500

Contains DI Package

00810011730212

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case