Duns Number:008965063
Device Description: One Step Menopause Test - 1 Test With Insert
Catalog Number
-
Brand Name
Walgreens
Version/Model Number
MidStream 6
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
NGA
Product Code Name
Test, Follicle Stimulating Hormone (Fsh), Over The Counter
Public Device Record Key
adeb157b-763a-44f5-add6-5237e1ac26bb
Public Version Date
April 02, 2020
Public Version Number
1
DI Record Publish Date
March 25, 2020
Package DI Number
10311917215751
Quantity per Package
48
Contains DI Package
00311917215754
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipping Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 75 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 74 |
| U | Unclassified | 2 |