Sunbeam
GUDID 16970289035318
Infrared Body Thermometer
Hetaida Technology Co., Ltd
Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin Infrared patient thermometer, skin| Primary Device ID | 16970289035318 |
| NIH Device Record Key | 4a8bbfc7-1cb4-4c48-9cfc-69015002146a |
| Commercial Distribution Discontinuation | 2021-07-31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sunbeam |
| Version Model Number | HTD8216C |
| Company DUNS | 544474402 |
| Company Name | Hetaida 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 | false |
| 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
| Phone | +86076982658050 |
| tomchen@hetaida.com.cn | |
| Phone | +86076982658050 |
| tomchen@hetaida.com.cn | |
| Phone | +86076982658050 |
| tomchen@hetaida.com.cn | |
| Phone | +86076982658050 |
| tomchen@hetaida.com.cn | |
| Phone | +86076982658050 |
| tomchen@hetaida.com.cn | |
| Phone | +86076982658050 |
| tomchen@hetaida.com.cn | |
| Phone | +86076982658050 |
| tomchen@hetaida.com.cn | |
| Phone | +86076982658050 |
| tomchen@hetaida.com.cn | |
| Phone | +86076982658050 |
| tomchen@hetaida.com.cn | |
| Phone | +86076982658050 |
| tomchen@hetaida.com.cn | |
| Phone | +86076982658050 |
| tomchen@hetaida.com.cn | |
| Phone | +86076982658050 |
| tomchen@hetaida.com.cn | |
| Phone | +86076982658050 |
| tomchen@hetaida.com.cn | |
| Phone | +86076982658050 |
| tomchen@hetaida.com.cn | |
| Phone | +86076982658050 |
| tomchen@hetaida.com.cn | |
| Phone | +86076982658050 |
| tomchen@hetaida.com.cn | |
| Phone | +86076982658050 |
| tomchen@hetaida.com.cn | |
| Phone | +86076982658050 |
| tomchen@hetaida.com.cn | |
| Phone | +86076982658050 |
| tomchen@hetaida.com.cn | |
| Phone | +86076982658050 |
| tomchen@hetaida.com.cn | |
| Phone | +86076982658050 |
| tomchen@hetaida.com.cn | |
| Phone | +86076982658050 |
| tomchen@hetaida.com.cn | |
| Phone | +86076982658050 |
| tomchen@hetaida.com.cn |
Device Dimensions
| Height | 52 Centimeter |
| Width | 34 Centimeter |
| Length | 154 Centimeter |
| Height | 52 Centimeter |
| Width | 34 Centimeter |
| Length | 154 Centimeter |
| Height | 52 Centimeter |
| Width | 34 Centimeter |
| Length | 154 Centimeter |
| Height | 52 Centimeter |
| Width | 34 Centimeter |
| Length | 154 Centimeter |
| Height | 52 Centimeter |
| Width | 34 Centimeter |
| Length | 154 Centimeter |
| Height | 52 Centimeter |
| Width | 34 Centimeter |
| Length | 154 Centimeter |
| Height | 52 Centimeter |
| Width | 34 Centimeter |
| Length | 154 Centimeter |
| Height | 52 Centimeter |
| Width | 34 Centimeter |
| Length | 154 Centimeter |
| Height | 52 Centimeter |
| Width | 34 Centimeter |
| Length | 154 Centimeter |
| Height | 52 Centimeter |
| Width | 34 Centimeter |
| Length | 154 Centimeter |
| Height | 52 Centimeter |
| Width | 34 Centimeter |
| Length | 154 Centimeter |
| Height | 52 Centimeter |
| Width | 34 Centimeter |
| Length | 154 Centimeter |
| Height | 52 Centimeter |
| Width | 34 Centimeter |
| Length | 154 Centimeter |
| Height | 52 Centimeter |
| Width | 34 Centimeter |
| Length | 154 Centimeter |
| Height | 52 Centimeter |
| Width | 34 Centimeter |
| Length | 154 Centimeter |
| Height | 52 Centimeter |
| Width | 34 Centimeter |
| Length | 154 Centimeter |
| Height | 52 Centimeter |
| Width | 34 Centimeter |
| Length | 154 Centimeter |
| Height | 52 Centimeter |
| Width | 34 Centimeter |
| Length | 154 Centimeter |
| Height | 52 Centimeter |
| Width | 34 Centimeter |
| Length | 154 Centimeter |
| Height | 52 Centimeter |
| Width | 34 Centimeter |
| Length | 154 Centimeter |
| Height | 52 Centimeter |
| Width | 34 Centimeter |
| Length | 154 Centimeter |
| Height | 52 Centimeter |
| Width | 34 Centimeter |
| Length | 154 Centimeter |
| Height | 52 Centimeter |
| Width | 34 Centimeter |
| Length | 154 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06970289035311 [Primary] |
| GS1 | 16970289035318 [Package] Contains: 06970289035311 Package: [40 Units] Discontinued: 2021-07-31 In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K180385
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 | 2021-07-05 |
| Device Publish Date | 2021-06-25 |
Devices Manufactured by Hetaida Technology Co., Ltd
| 16970289035646 - Hetaida | 2024-03-22 |
| 16970289035677 - hetaida | 2024-03-22 Non Contact Infrared Body Thermometer |
| 16970289035684 - Hetaida | 2024-03-22 Electronic blood pressure monitor |
| 16970289035691 - Hetaida | 2024-03-22 Electric Nasal Aspirator |
| 16970289035639 - LPOW | 2024-02-05 Electronic blood pressure monitor |
| 16970289035622 - femometer family | 2024-02-02 Infrared Body Thermometer |
| 16970289035615 - Hetaida | 2024-01-08 Electronic blood pressure monitor |
| 16970289035608 - Hetaida | 2023-12-19 Electronic blood pressure monitor |
Trademark Results [Sunbeam]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SUNBEAM 97864041 not registered Live/Pending |
Sunbeam Products, Inc. 2023-03-30 |
 SUNBEAM 97438523 not registered Live/Pending |
Sunbeam Products, Inc. 2022-06-01 |
 SUNBEAM 97438443 not registered Live/Pending |
Sunbeam Products, Inc. 2022-06-01 |
 SUNBEAM 90846143 not registered Live/Pending |
Fior di Sole, LLC 2021-07-23 |
 SUNBEAM 90845607 not registered Live/Pending |
Leiio Wellness Ltd. 2021-07-23 |
 SUNBEAM 90583957 not registered Live/Pending |
SUNTORY FLOWERS LIMITED 2021-03-17 |
 SUNBEAM 88429065 not registered Live/Pending |
Basic, Inc. 2019-05-14 |
 SUNBEAM 87328607 not registered Live/Pending |
Quality Bakers of America Cooperative, Inc. 2017-02-08 |
 SUNBEAM 87276075 5459991 Live/Registered |
TRC Recreation, LP 2016-12-21 |
 SUNBEAM 87118566 not registered Dead/Abandoned |
Hughes Michael T. 2016-07-27 |
 SUNBEAM 86898955 not registered Dead/Abandoned |
Taylor, Vincent 2016-02-05 |
 SUNBEAM 86789377 not registered Dead/Abandoned |
Taylor, Vincent 2015-10-15 |
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