Pro Voice - Blood Glucose Test Strips - FORACARE TEXAS, INC

Duns Number:028662035

Device Description: Blood Glucose Test Strips

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More Product Details

Catalog Number

-

Brand Name

Pro Voice

Version/Model Number

V8/V9

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K072039,K090188,K072039,K090188

Product Code Details

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Device Record Status

Public Device Record Key

93ad6d1b-7985-4f24-ab90-a2159fc767de

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 01, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FORACARE TEXAS, INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2