Duns Number:012430880
Device Description: CardioChek 15Lipid/15Glucose
Catalog Number
5700412
Brand Name
CardioChek
Version/Model Number
5700412
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)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K023558,K022898,K023558,K140068,K140068,K023558,K022898,K140068,K022898
Product Code
CGA
Product Code Name
GLUCOSE OXIDASE, GLUCOSE
Public Device Record Key
9c57b087-ee22-4459-b89e-df3c69bb4ba7
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 05, 2017
Package DI Number
20304040037731
Quantity per Package
15
Contains DI Package
10304040037734
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3829 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2579 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 34 |