FDA UDI
In Commercial Distribution
🇺🇸 United States
Vivoo
DI: 00860011489160
·
Model: VWHL25V1
·
VIVOSENS INC.
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
30
Basic Information
- Brand Name
- Vivoo
- Primary DI
- 00860011489160
- Version / Model
- VWHL25V1
- Company Name
- VIVOSENS INC.
- Labeler DUNS
- 086601609
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2024-11-25
- Public Version
- 1
- Public Version Date
- 2024-12-03
- Public Version Status
- New
- Public Device Record Key
- 2fd57f49-88a0-4061-b568-94c5d4421d44
Device Description
5-Strip HCG Pregnancy Tests, 25-Strip LH-Ovulation Test, and 30 Plastic Urine Cups
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- 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 | 10860011489167 | GS1 | Carton | 30 | In Commercial Distribution | |
| Primary | 00860011489160 | GS1 | ||||
| Unit of Use | 20860011489164 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233624 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius