Duns Number:025460908
Device Description: STRIP, GLUCOSE, FOIL, G3, PROF.USE ONLY
Catalog Number
MPH3550FL
Brand Name
MEDLINE INDUSTRIES, INC.
Version/Model Number
MPH3550FL
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"
Yes
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
2d489694-e7f4-4b07-be28-506307a6a487
Public Version Date
October 11, 2021
Public Version Number
1
DI Record Publish Date
October 01, 2021
Package DI Number
30888277365944
Quantity per Package
50
Contains DI Package
10888277365940
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| 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 |