Duns Number:849098897
Device Description: 2+10 Mini-Midstream Combo; 2 hCG Pregnancy Test + 10 LH Ovulation Test
Catalog Number
WMII-H2L10
Brand Name
Preview
Version/Model Number
WMII-H2L10
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)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K043443,K043443,K043443
Product Code
JHI
Product Code Name
Visual, Pregnancy Hcg, Prescription Use
Public Device Record Key
96535ff0-fc6e-455b-b00d-a642b1742531
Public Version Date
October 31, 2022
Public Version Number
4
DI Record Publish Date
March 01, 2017
Package DI Number
10816862020967
Quantity per Package
70
Contains DI Package
00816862020960
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 87 |
| U | Unclassified | 1 |