Duns Number:008965063
Device Description: A convenience kit consisting of 1 Walgreens Digital Pregnancy Test and 1 Walgreens One Ste A convenience kit consisting of 1 Walgreens Digital Pregnancy Test and 1 Walgreens One Step Pregnancy Test
Catalog Number
-
Brand Name
Walgreens
Version/Model Number
Digital & One Step Pregnancy Tests
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
K042280,K060128,K042280,K060128
Product Code
LCX
Product Code Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Public Device Record Key
9e06369d-ad7f-4a16-acb7-bf08b8270da7
Public Version Date
March 28, 2019
Public Version Number
1
DI Record Publish Date
March 20, 2019
Package DI Number
10311917207992
Quantity per Package
24
Contains DI Package
00311917207995
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 |