FDA UDI
In Commercial Distribution
🇺🇸 United States
Beurer
DI: 00850003500645
·
Model: FT90
·
BEURER NORTH AMERICA, L.P.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Beurer
- Primary DI
- 00850003500645
- Version / Model
- FT90
- Catalog Number
- Type FT90/1 (795.71)
- 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
- 2020-04-23
- Public Version
- 2
- Public Version Date
- 2020-12-04
- Public Version Status
- Update
- Public Device Record Key
- d9767960-5667-4572-b9e9-186539cd0de2
Device Description
Non-contact IR Clinical Thermometer
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
- 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 |
|---|---|---|---|---|
| FLL | Thermometer, Electronic, Clinical | General Hospital | 880.2910 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17888 | Infrared patient thermometer, skin | A hand-held, electrically-powered instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850003500642 | GS1 | Inner Pack | 4 | In Commercial Distribution | |
| Primary | 00850003500645 | GS1 | ||||
| Package | 20850003500649 | GS1 | Case Pack | 8 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-800-536-0366
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 122 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 50 Degrees Celsius