FDA UDI In Commercial Distribution 🇺🇸 United States

Easy@Home Ovulation Test Kit (25 LH strips + 10 HCG strips + 40 Cups )

DI: 00810038634487 · Model: EZW2-S, EZW1-S · EASY HEALTHCARE CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
35

Basic Information

Brand Name
Easy@Home Ovulation Test Kit (25 LH strips + 10 HCG strips + 40 Cups )
Primary DI
00810038634487
Version / Model
EZW2-S, EZW1-S
Catalog Number
EZ-WS2510C40
Company Name
EASY HEALTHCARE CORPORATION
Labeler DUNS
080278407
Distribution Status
In Commercial Distribution
Device Count in Pkg
35
Record Status
Published
Publish Date
2023-01-09
Public Version
1
Public Version Date
2023-01-17
Public Version Status
New
Public Device Record Key
9e7c77dd-8301-4f14-9e03-3294fbb51469

Device Description

25 LH strips +10HCG strips + 40 Cups ;Ovulation Test Kit

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 10810038634484
Primary 00810038634487
Unit of Use 30810038634488