TRUEplus - Rite Aid TRUEplus Safety Lancets - TRIVIDIA HEALTH, INC.

Duns Number:151810868

Device Description: Rite Aid TRUEplus Safety Lancets

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More Product Details

Catalog Number

S7066RN28-25

Brand Name

TRUEplus

Version/Model Number

Rite Aid TRUEplus Safety Lancets

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

FMK

Product Code Name

Lancet, Blood

Device Record Status

Public Device Record Key

0bfd9d4f-3dbf-4b1b-956e-eda10a1c05f4

Public Version Date

November 02, 2020

Public Version Number

1

DI Record Publish Date

October 23, 2020

Additional Identifiers

Package DI Number

10011822463307

Quantity per Package

24

Contains DI Package

00011822463300

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"TRIVIDIA HEALTH, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 25
2 A medical device with a moderate to high risk that requires special controls. 22