FDA UDI
In Commercial Distribution
🇺🇸 United States
Easy@Home Ovulation Test Kit (40 LH strips + 10 HCG strips )
DI: 00850253007635
·
Model: EZ-WS4010
·
EASY HEALTHCARE CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
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Basic Information
- Brand Name
- Easy@Home Ovulation Test Kit (40 LH strips + 10 HCG strips )
- Primary DI
- 00850253007635
- Version / Model
- EZ-WS4010
- Catalog Number
- EZW2-S, EZW1-S
- Company Name
- EASY HEALTHCARE CORPORATION
- Labeler DUNS
- 080278407
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- 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
- cb89f28e-564f-4780-be91-83813dc7d771
Device Description
40 LH strips + 10 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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | Clinical Chemistry | 862.1155 | 2 |
| CEP | Radioimmunoassay, Luteinizing Hormone | Clinical Chemistry | 862.1485 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60862 | Natural conception assistance kit | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850253007632 | GS1 | 80 | In Commercial Distribution | ||
| Primary | 00850253007635 | GS1 | ||||
| Unit of Use | 30850253007636 | GS1 |