FDA UDI In Commercial Distribution 🇺🇸 United States

Easy@Home Ovulation Test Kit (50 LH strips + 20 HCG strips )

DI: 00850253007611 · Model: EZ-WS5020 · EASY HEALTHCARE CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
70

Basic Information

Brand Name
Easy@Home Ovulation Test Kit (50 LH strips + 20 HCG strips )
Primary DI
00850253007611
Version / Model
EZ-WS5020
Catalog Number
EZW2-S, EZW1-S
Company Name
EASY HEALTHCARE CORPORATION
Labeler DUNS
080278407
Distribution Status
In Commercial Distribution
Device Count in Pkg
70
Record Status
Published
Publish Date
2016-09-15
Public Version
4
Public Version Date
2019-02-21
Public Version Status
Update
Public Device Record Key
3480b527-f578-4cb1-b991-f2ca905f7fbc

Device Description

50 LH strips + 20 HCG strips

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
Yes
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LCX Kit, Test, Pregnancy, Hcg, Over The Counter
CEP Radioimmunoassay, Luteinizing Hormone

GMDN Terms

Code Name
60862 Natural conception assistance kit

Identifiers

Type ID
Package 10850253007618
Primary 00850253007611
Unit of Use 30850253007612