FDA UDI
Not in Commercial Distribution
🇺🇸 United States
The Fitness Family
DI: 00866066000305
·
Model: 001
·
GMB INTERNATIONAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- The Fitness Family
- Primary DI
- 00866066000305
- Version / Model
- 001
- 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
- 3
- Public Version Date
- 2018-12-31
- Public Version Status
- Update
- Public Device Record Key
- e06d139f-65b0-4598-8aaf-d419fdb56bac
- Distribution End Date
- 2018-12-31
Device Description
A digital thermometer designed to measure body temperature orally, rectally or under the arm. It has a silicon & plastic structure, a metal sensing tip and a battery-powered chip and LCD screen. It is for multiple uses.
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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FLL | Thermometer, Electronic, Clinical | General Hospital | 880.2910 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14025 | Thermometer kit | A collection of devices intended to be used to eliminate the reprocessing, reduce the risk of breakage and cross-contamination, and reduce the variance caused by the use of more than one thermometer per patient. It typically includes a thermometer [e.g., a mercury (Hg) or alcohol thermometer] for measuring human body temperature; and other components such as holders, cases, vials, or sheaths. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00866066000305 | GS1 |
Customer Contacts
- Phone
- 9715337694
- [email protected]