FaceLake
GUDID 00851908007222
This thermometer can measure body's temperature
LORTE TECHNOLOGIES, INC
General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use| Primary Device ID | 00851908007222 |
| NIH Device Record Key | ae883b28-cbbf-4fb2-bcab-3d5ddab7d2f3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FaceLake |
| Version Model Number | FT82 |
| Company DUNS | 029578633 |
| Company Name | LORTE TECHNOLOGIES, INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851908007222 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K101387
FDA Product Code
| FLL | Thermometer, Electronic, Clinical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-17 |
| Device Publish Date | 2020-12-09 |
On-Brand Devices [FaceLake]
| 00851908007161 | The FD-300B is a ultrasonic Doppler that allows expectant mothers and health care professionals |
| 00851908007130 | The FD-300P is a ultrasonic Doppler that allows expectant mothers and health care professionals |
| 00851908007123 | The Facelake FL-420 finger pulse oximeter is a lightweight, portable device used for measuring b |
| 00851908007116 | The FD-200P is a ultrasonic Doppler that allows expectant mothers and health care professionals |
| 00851908007109 | The FD-200B is a ultrasonic Doppler that allows expectant mothers and health care professionals |
| 00851908007093 | JPD-100B Ultrasonic Doppler Fetal Heartbeat Detector is an equipment to detect the fetal heartbe |
| 00851908007086 | Used for spot-checking blood oxygen saturation levels and pulse rate. |
| 00851908007079 | The CMS-50F is a wrist pulse oximeter designed to help monitor blood oxygen levels and heart rat |
| 00851908007062 | The 50EW is a rechargeable pulse oximeter that is designed to accurately measure oxygen saturati |
| 00851908007055 | Handheld pulse oximeter used to monitor blood oxygen levels and heart rate |
| 00851908007048 | The Sonoline B Fetal Doppler is a ultrasonic Doppler that allows expectant mothers and health ca |
| 00851908007031 | The 50E is a rechargeable pulse oximeter designed to accurately measure oxygen saturation (SpO2) |
| 00851908007024 | The CMS-50D Plus finger pulse oximeter is a lightweight, portable device used for measuring both |
| 00851908007017 | The Facelake FL-400 finger pulse oximeter is a lightweight, portable device used for measuring b |
| 00851908007000 | The Facelake FL-350 finger pulse oximeter is a lightweight, portable device used for measuring b |
| 00851908007222 | This thermometer can measure body's temperature |
Trademark Results [FaceLake]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FACELAKE 98148195 not registered Live/Pending |
Lorte technologies inc 2023-08-24 |
 FACELAKE 86760349 5079376 Live/Registered |
Lorte Technologies Inc 2015-09-17 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.