FDA UDI
In Commercial Distribution
🇺🇸 United States
Beurer
DI: 00850003500430
·
Model: OT20
·
BEURER NORTH AMERICA, L.P.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Beurer
- Primary DI
- 00850003500430
- Version / Model
- OT20
- Catalog Number
- 790.70
- Company Name
- BEURER NORTH AMERICA, L.P.
- Labeler DUNS
- 078497467
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-09
- Public Version
- 4
- Public Version Date
- 2020-11-17
- Public Version Status
- Update
- Public Device Record Key
- 80068185-11ad-4997-81b6-f22c363942da
Device Description
Ovy by Beurer Basal Thermometer with Ovy App
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|---|---|
| Package | 20850003500434 | GS1 | Case Pack | 18 | Not in Commercial Distribution | 2020-11-16 |
| Package | 10850003500437 | GS1 | Inner Pack | 10 | Not in Commercial Distribution | 2020-11-16 |
| Primary | 00850003500430 | GS1 |
Customer Contacts
- Phone
- 1-800-536-0366
- [email protected]