Model: Smart Ovulation Test
Catalog: N/A
DI: 00633472602566
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-05-06
Current Version: 2026-05-14
Description
CLEARBLUE OVUL SOT 20CT US
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
cede02c4-d4ea-49a4-af54-5c3839e71865
Distribution Status:
In Commercial Distribution
DUNS Number:
483609579
Device Count:
20
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
Shipping case
Item #1 - Device ID:
10633472602563
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
6
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00633472602566
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00633472602566
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
00633472000676
Item #3 - Device ID Type:
Unit of Use
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 60862
Name: Natural conception assistance kit
Definition:
A collection of devices intended to improve the likelihood of natural conception by monitoring ovulation and supplementing essential vitamins. The kit may contain in vitro diagnostic medical devices (IVDs) such as immunochromatographic tests for ovulation and pregnancy detection, a digital thermometer, vitamin supplements for the male and the female, and instructions for use.
FDA Product Codes
NGE
Test, Luteinizing Hormone (Lh), Over The Counter
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
2
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
30
Storage Handling - Storage Handling Type:
Storage Environment Temperature