Duns Number:829984561
Device Description: 4 bags/pieces Livongo Test Strips, 8 bags/pieces Livongo Sterile Lancets, 1 Instructions f 4 bags/pieces Livongo Test Strips, 8 bags/pieces Livongo Sterile Lancets, 1 Instructions for Use (English), 1 Instructions for Use (Spanish)
Catalog Number
KIT01209
Brand Name
Livongo Refill Kit
Version/Model Number
200/200
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
K133584
Product Code
CGA
Product Code Name
Glucose Oxidase, Glucose
Public Device Record Key
18b677f7-0a06-4f21-bfdb-7a78fe5af904
Public Version Date
September 20, 2018
Public Version Number
1
DI Record Publish Date
August 20, 2018
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 29 |