Duns Number:116979417
Device Description: The BioTel Care® Blood Glucose Monitoring System consists of a meter, test strips, and con The BioTel Care® Blood Glucose Monitoring System consists of a meter, test strips, and control solutions (Level 1 and Level 2). The BioTel Care® Blood Glucose Meter, when used with the BioTel Care® Blood Glucose Test Strip, quantitatively measures glucose in capillary whole blood. The BioTel Care® Glucose Control Solutions are used by patients to verify the performance of the BioTel Care® test strips and BioTel Care® meter.
Catalog Number
TM0008
Brand Name
BioTel Care® Blood Glucose Monitoring System
Version/Model Number
BGM
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
K110571,K110571
Product Code
NBW
Product Code Name
System, Test, Blood Glucose, Over The Counter
Public Device Record Key
aba65b22-e349-452a-ae76-b9f9d4a28f29
Public Version Date
March 19, 2019
Public Version Number
1
DI Record Publish Date
March 11, 2019
Package DI Number
00859519002339
Quantity per Package
16
Contains DI Package
00859519002223
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |