Duns Number:545852548
Device Description: Blood glucose monitoring system, it contains blood glucose meter, blood glucose test strip Blood glucose monitoring system, it contains blood glucose meter, blood glucose test strips, lancing device and sterile lancet.
Catalog Number
-
Brand Name
COLEBY
Version/Model Number
G-427B
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
-
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
K191657,K191657,K191657
Product Code
NBW
Product Code Name
System, Test, Blood Glucose, Over The Counter
Public Device Record Key
3ee4b535-8433-49f5-b990-29c8f8cf502a
Public Version Date
November 15, 2021
Public Version Number
1
DI Record Publish Date
November 05, 2021
Package DI Number
16939184630233
Quantity per Package
20
Contains DI Package
06939184630236
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |