Exergen DermaTemp 124160
GUDID 10834098000522
DT-2000 Bluetooth
EXERGEN CORPORATION
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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