Duns Number:025460908
Device Description: STRIP,GLUCOSE,EVENCARE G3,PROF.USE ONLY
Catalog Number
MPH3550
Brand Name
Medline
Version/Model Number
MPH3550
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
K120448,K120448,K120448
Product Code
NBW
Product Code Name
System, test, blood glucose, over the counter
Public Device Record Key
751dd092-198c-471b-9669-77f7a3ae7958
Public Version Date
December 02, 2020
Public Version Number
1
DI Record Publish Date
November 24, 2020
Package DI Number
40884389831206
Quantity per Package
600
Contains DI Package
30884389831209
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |