GL GoodLife - GL GoodLife Blood Glucose Monitoring - HMD BIOMEDICAL INC.

Duns Number:658644174

Device Description: GL GoodLife Blood Glucose Monitoring System(Cloudia)

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More Product Details

Catalog Number

3K-01-810037

Brand Name

GL GoodLife

Version/Model Number

IG01

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 13, 2017

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"

Yes

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

K131173,K131173

Product Code Details

Product Code

JJX

Product Code Name

Single (Specified) Analyte Controls (Assayed And Unassayed)

Device Record Status

Public Device Record Key

1c87ebd1-d478-4e0a-9d57-70736ceb00c2

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 07, 2016

Additional Identifiers

Package DI Number

00389154000471

Quantity per Package

60

Contains DI Package

00389154000372

Package Discontinue Date

March 13, 2017

Package Status

Not in Commercial Distribution

Package Type

-

"HMD BIOMEDICAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15
2 A medical device with a moderate to high risk that requires special controls. 16