Exergen DermaTemp 124160
GUDID 10834098000522
DT-2000 Bluetooth
EXERGEN CORPORATION
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 | 10834098000522 |
| NIH Device Record Key | f83c9ed3-2f13-43e4-9fdd-c8219894e3c8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Exergen DermaTemp |
| Version Model Number | DT-2000 BT |
| Catalog Number | 124160 |
| Company DUNS | 061266060 |
| Company Name | EXERGEN CORPORATION |
| 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 | 617-923-9900 |
| medical@exergen.com | |
| Phone | 617-923-9900 |
| medical@exergen.com | |
| Phone | 617-923-9900 |
| medical@exergen.com | |
| Phone | 617-923-9900 |
| medical@exergen.com | |
| Phone | 617-923-9900 |
| medical@exergen.com | |
| Phone | 617-923-9900 |
| medical@exergen.com | |
| Phone | 617-923-9900 |
| medical@exergen.com | |
| Phone | 617-923-9900 |
| medical@exergen.com | |
| Phone | 617-923-9900 |
| medical@exergen.com | |
| Phone | 617-923-9900 |
| medical@exergen.com | |
| Phone | 617-923-9900 |
| medical@exergen.com | |
| Phone | 617-923-9900 |
| medical@exergen.com | |
| Phone | 617-923-9900 |
| medical@exergen.com | |
| Phone | 617-923-9900 |
| medical@exergen.com | |
| Phone | 617-923-9900 |
| medical@exergen.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10834098000522 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K873010
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 | 2019-06-21 |
| Device Publish Date | 2019-06-13 |
On-Brand Devices [Exergen DermaTemp]
| 10834098000522 | DT-2000 Bluetooth |
| 10834098000508 | DT-RS232, Dermatemp RS-232 |
| 10834098000379 | DermaTemp 1001 R/S |
| 10834098000355 | Dermatemp 1001 LN |
Trademark Results [Exergen DermaTemp]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EXERGEN DERMATEMP 98458240 not registered Live/Pending |
Exergen Corporation 2024-03-20 |
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