Fanle
GUDID 10810021178315
Dongguan SIMZO Electronic Technology Co., Ltd.
Infrared patient thermometer, skin| Primary Device ID | 10810021178315 |
| NIH Device Record Key | 803d7d4f-d205-43d4-a5b6-7e1db2fdc78b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fanle |
| Version Model Number | HW-F7 |
| Company DUNS | 544332470 |
| Company Name | Dongguan SIMZO Electronic Technology Co., Ltd. |
| 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 | false |
| 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 | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810021178318 [Primary] |
| GS1 | 10810021178315 [Package] Contains: 00810021178318 Package: [1 Units] In Commercial Distribution |
| GS1 | 20810021178329 [Package] Package: [2 Units] In Commercial Distribution |
| GS1 | 20810021178336 [Package] Package: [60 Units] In Commercial Distribution |
| GS1 | 30810021178043 [Package] Contains: 20810021178329 Package: [30 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K173048
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 | 2020-09-02 |
| Device Publish Date | 2020-08-25 |
Devices Manufactured by Dongguan SIMZO Electronic Technology Co., Ltd.
| 00810021174013 - NA | 2024-01-11 |
| 10810021174034 - NA | 2024-01-11 |
| 00810021171166 - SIMZO | 2021-07-28 |
| 00810021171173 - SIMZO | 2021-07-28 |
| 00810021171180 - SIMZO | 2021-07-28 |
| 00810021171197 - simzo | 2021-07-28 |
| 00810021171203 - SIMZO | 2021-07-28 |
| 00810021171210 - SIMZO | 2021-07-28 |
Trademark Results [Fanle]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FANLE 87840682 5586162 Live/Registered |
Huizhou OuGaiSen Electronic Commerce Co.,Ltd. 2018-03-19 |
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