FDA UDI
In Commercial Distribution
🇺🇸 United States
Easy@Home Ovulation Test Kit (15 LH Midstreams+5 HCG Midstreams)
DI: 00855944007086
·
Model: EZW2-M , EZW1-M
·
EASY HEALTHCARE CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
20
Basic Information
- Brand Name
- Easy@Home Ovulation Test Kit (15 LH Midstreams+5 HCG Midstreams)
- Primary DI
- 00855944007086
- Version / Model
- EZW2-M , EZW1-M
- Catalog Number
- EZM1-L15H5
- Company Name
- EASY HEALTHCARE CORPORATION
- Labeler DUNS
- 080278407
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2018-07-01
- Public Version
- 2
- Public Version Date
- 2019-02-21
- Public Version Status
- Update
- Public Device Record Key
- ba7e74f4-0268-48bf-9c85-8866514fcfd3
Device Description
Easy@Home 15 Ovulation (LH) and Plus 5 Pregnancy (hCG) Test Sticks
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 |
|---|---|---|---|---|
| CEP | Radioimmunoassay, Luteinizing Hormone | Clinical Chemistry | 862.1485 | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | Clinical Chemistry | 862.1155 | 2 |
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 | 10855944007083 | GS1 | Carton | 48 | In Commercial Distribution | |
| Primary | 00855944007086 | GS1 | ||||
| Unit of Use | 30855944007087 | GS1 |