IDEAL LIFE Blood Glucose Test Strips 50 Test Strips(2vials of 25 Test Strips) - Ideal Life Inc

Duns Number:205155174

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More Product Details

Catalog Number

-

Brand Name

IDEAL LIFE Blood Glucose Test Strips 50 Test Strips(2vials of 25 Test Strips)

Version/Model Number

AGS-1112

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

CGA

Product Code Name

Glucose Oxidase, Glucose

Device Record Status

Public Device Record Key

102cd6f9-4072-403d-ad9d-f60d29f13787

Public Version Date

August 07, 2019

Public Version Number

2

DI Record Publish Date

July 22, 2019

Additional Identifiers

Package DI Number

10804084000140

Quantity per Package

50

Contains DI Package

00804084000143

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"IDEAL LIFE INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 1