Duns Number:483609579
Device Description: Exchange Select One Step Ovulation Predictor
Catalog Number
-
Brand Name
Exchange Select
Version/Model Number
One Step Ovulation Predictor
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 06, 2022
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
CEP
Product Code Name
Radioimmunoassay, Luteinizing Hormone
Public Device Record Key
b1f73251-1090-4b3d-ac70-94a5469c3fd1
Public Version Date
June 07, 2022
Public Version Number
2
DI Record Publish Date
March 01, 2019
Package DI Number
10614299396439
Quantity per Package
6
Contains DI Package
00614299396432
Package Discontinue Date
June 06, 2022
Package Status
Not 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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |