Duns Number:025460908
Device Description: STRIP,TEST,GLUCOSE,HARMONY
Catalog Number
MPH6550
Brand Name
Medline
Version/Model Number
MPH6550
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
K161299,K161299,K161299
Product Code
NBW
Product Code Name
System, test, blood glucose, over the counter
Public Device Record Key
bb72a1ba-3ef9-47b4-b3f0-0e289a566194
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
December 11, 2020
Package DI Number
20888277675688
Quantity per Package
50
Contains DI Package
10888277675681
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 |