Duns Number:658447255
Device Description: Perfect 3 Blood Glucose Test Strip1.Part Number:BY8818G0NL42.Packing Materials No.:BL8818P Perfect 3 Blood Glucose Test Strip1.Part Number:BY8818G0NL42.Packing Materials No.:BL8818PEA
Catalog Number
-
Brand Name
Perfect 3
Version/Model Number
8818
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
-
Product Code
CGA
Product Code Name
Glucose Oxidase, Glucose
Public Device Record Key
80d92d8c-e923-4a2d-b6be-827f772bc960
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 23, 2017
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 | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |