FDA UDI
Not in Commercial Distribution
🇺🇸 United States
The Fitness Family
DI: 00866066000312
·
Model: 002
·
GMB INTERNATIONAL LIMITED
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- The Fitness Family
- Primary DI
- 00866066000312
- Version / Model
- 002
- Company Name
- GMB INTERNATIONAL LIMITED
- Labeler DUNS
- 221516566
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-13
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- b278a28f-ea6d-4ba2-a5df-e665988049bc
- Distribution End Date
- 2017-12-31
Device Description
A digital thermometer that measures body temperature orally, rectally or under the arm. It has a plastic exterior, a metal sensing tip and a battery-powered LCD screen which displays results to 2 decimal places. It comes with a plastic protective case.
Device Characteristics
- Single Use
- No
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
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 | 00866066000312 | GS1 |
Customer Contacts
- Phone
- 9715337694
- [email protected]