Duns Number:835772872
Device Description: CardioChek Plus Home Lipid + eGLU Smart Bundle Self-Test test strips are in vitro diagnost CardioChek Plus Home Lipid + eGLU Smart Bundle Self-Test test strips are in vitro diagnostic devices used to measure glucose and lipid (total cholesterol / HDL cholesterol / and triglyceride) levels in human whole blood from the fingertip. These test strips must be used in conjunction with a CardioChek Plus Home Self-Test analyzer.
Catalog Number
4721
Brand Name
CardioChek Plus Home Lipid + eGLU Smart Bundle Self-Test 2ct
Version/Model Number
4721
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
K022898,K023558,K140068,K022898,K023558,K140068
Product Code
CGA
Product Code Name
GLUCOSE OXIDASE, GLUCOSE
Public Device Record Key
2d32b6ac-c3f0-4d91-adc2-498ea953d0cb
Public Version Date
April 13, 2022
Public Version Number
2
DI Record Publish Date
February 08, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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. | 1 |