ACCU-CHEK PERFORMA - ACCU-CHEK PERFORMA PROF METER KIT US F2 - Roche Diagnostics Operations, Inc.

Duns Number:141608724

Device Description: ACCU-CHEK PERFORMA PROF METER KIT US F2

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

05959551001

Brand Name

ACCU-CHEK PERFORMA

Version/Model Number

05959551001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 14, 2021

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Device Record Status

Public Device Record Key

752ebefd-e1a7-478d-8ee5-f91e67320926

Public Version Date

January 15, 2021

Public Version Number

3

DI Record Publish Date

August 26, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ROCHE DIAGNOSTICS OPERATIONS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 63
3 A medical device with high risk that requires premarket approval 3