FDA UDI
In Commercial Distribution
🇺🇸 United States
Lady-Comp
DI: 07629999894334
·
Model: 894334
·
Valley Electronics AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Lady-Comp
- Primary DI
- 07629999894334
- Version / Model
- 894334
- Company Name
- Valley Electronics AG
- Labeler DUNS
- 487409286
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-07
- Public Version
- 1
- Public Version Date
- 2022-12-15
- Public Version Status
- New
- Public Device Record Key
- 0324aae6-3480-4017-b880-a4c3fe2b7c44
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| LHD | Device, Fertility Diagnostic, Proceptive | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36110 | Thermometric fertility analyser | A hand-operated, battery-powered, electronic, instrument used for recording basal body temperature and cycle length to identify the fertile and infertile phases of the menstrual cycle. The device consists of a basal body temperature thermometer and a microprocessor programmed with a mathematical algorithm to calculate and identify temperature shifts. It is used to predict ovulation to optimize the chances for becoming pregnant or for determining safe periods where sexual intercourse may take place. It is typically a noninvasive, automatic device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07629999894334 | GS1 |
Customer Contacts
- Phone
- 18779255239
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 60 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 93 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal