FDA UDI
In Commercial Distribution
🇺🇸 United States
Premom Ovulation Tests (50 LH strips + 20 HCG strips)
DI: 00810038630465
·
Model: PMS2-S, PMS1-S
·
EASY HEALTHCARE CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
70
Basic Information
- Brand Name
- Premom Ovulation Tests (50 LH strips + 20 HCG strips)
- Primary DI
- 00810038630465
- Version / Model
- PMS2-S, PMS1-S
- Catalog Number
- PMS-5020
- Company Name
- EASY HEALTHCARE CORPORATION
- Labeler DUNS
- 080278407
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 70
- Record Status
- Published
- Publish Date
- 2023-04-12
- Public Version
- 1
- Public Version Date
- 2023-04-20
- Public Version Status
- New
- Public Device Record Key
- 600c306f-ef5d-4389-ab80-5de46d99aac1
Device Description
50 LH strips + 20 HCG strips ;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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | Clinical Chemistry | 862.1155 | 2 |
| NGE | Test, Luteinizing Hormone (Lh), Over The Counter | 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 | 10810038630462 | GS1 | Carton | 60 | In Commercial Distribution | |
| Primary | 00810038630465 | GS1 | ||||
| Unit of Use | 30810038630466 | GS1 |