Duns Number:006922009
Device Description: Publix DPS +/- Blue Cap
Catalog Number
-
Brand Name
Publix
Version/Model Number
One Step Pregnancy Test
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,K042280,K042280
Product Code
LCX
Product Code Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Public Device Record Key
153b1392-ffc2-428a-8328-269993586b0b
Public Version Date
February 05, 2020
Public Version Number
1
DI Record Publish Date
January 28, 2020
Package DI Number
20041415096763
Quantity per Package
12
Contains DI Package
00041415096769
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 | 11 |
2 | A medical device with a moderate to high risk that requires special controls. | 17 |