OneTouch Verio - OneTouch Verio®Level 3 Control Solution - LifeScan Europe GmbH

Duns Number:480240820

Device Description: OneTouch Verio®Level 3 Control Solution

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More Product Details

Catalog Number

022-273

Brand Name

OneTouch Verio

Version/Model Number

022-273

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

-

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

LFR

Product Code Name

Glucose Dehydrogenase, Glucose

Device Record Status

Public Device Record Key

bb1a5a80-3bc6-449d-a25e-7ae9cf5570f5

Public Version Date

December 03, 2019

Public Version Number

1

DI Record Publish Date

November 25, 2019

Additional Identifiers

Package DI Number

20353885007768

Quantity per Package

48

Contains DI Package

00353885007764

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper case

"LIFESCAN EUROPE GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 17