| Primary Device ID | 10834098000546 |
| NIH Device Record Key | bd12ec44-eae3-44e7-86ca-0fa3f7c34656 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Exergen Temporal Scanner |
| Version Model Number | TAT-5000S-RS232-MUSB |
| Catalog Number | 124269-AF-GE |
| 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 | false |
| 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 |
| 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 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10834098000546 [Primary] |
| FLL | Thermometer, Electronic, Clinical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-29 |
| Device Publish Date | 2023-06-21 |
| 00834098002956 | TAT2000C Temporal Scanner |
| 00834098002949 | TAT2000C Temporal Scanner |
| 50834098002920 | TAT2000C Temporal Scanner |
| 00834098002918 | TAT2000C Original Temporal Scanner |
| 30834098002315 | TAT2000C Temporal Scanner |
| 10834098002106 | TAT2000C Temporal Scanner |
| 10834098002069 | TAT2000C Temporal Scanner |
| 10834098002045 | Kit with TAT5000 Arterial Calibration & 2000C Temporal Scanner |
| 10834098002038 | Kit with TAT5000 Oral Calibration & TAT2000C Temporal Scanner |
| 10834098002021 | Kit with TAT2000C Temporal Scanner & TAT5000 Arterial Calibration |
| 10834098000515 | TAT5000S Mindray |
| 10834098000492 | TAT5000S-USB Oral Calibration Generic |
| 10834098000485 | TAT5000S-USB Arterial Calibration Generic |
| 10834098000478 | TAT5000S-RS232-QR Arterial Calibration |
| 10834098000317 | TAT5000S-CORO Oral Calibration - Celcius |
| 10834098000300 | TAT5000S-CORO Oral Calibration - Fahrenheit |
| 10834098000294 | TAT5000S-CORO Arterial Calibration - Celcius |
| 10834098000287 | TAT5000S-CORO Arterial Calibration - Fahrenheit |
| 10834098000270 | TAT5000S Midmark |
| 10834098000263 | TAT5000S Capsule Tech |
| 10834098000256 | TAT5000S-USB Oral Calibration - Celcius |
| 10834098000249 | TAT5000S-USB Oral Calibration - Fahrenheit |
| 10834098000232 | TAT5000S-USB Arterial Calibration - Celcius |
| 10834098000225 | TAT5000S-USB Arterial Calibration - Fahrenheit |
| 10834098000218 | TAT5000S-TTL Oral Calibration - Celcius |
| 10834098000201 | TAT5000S-TTL Arterial Calibration - Celcius |
| 10834098000195 | TAT5000S-TTL Oral Calibration - Fahrenheit |
| 10834098000188 | TAT5000S-TTL Arterial Calibration - Fahrenheit |
| 10834098000171 | TAT5000 Dual Security 20 Oral Calibration |
| 10834098000164 | TAT5000 Dual Security 20 Arterial Calibration |
| 10834098000157 | TAT5000 Dual Security 5 Oral Calibration |
| 10834098000140 | TAT5000 Dual Security 5 Arterial Calibratiom |
| 10834098000133 | TAT5000 Quick Release Oral Calibration |
| 10834098000126 | TAT5000 Quick Release Arterial Calibration |
| 10834098000102 | TAT5000 Oral Calibration |
| 10834098000089 | TAT5000 Arterial Calibration |
| 10834098000539 | 124229-AF-EP |
| 10834098000591 | TAT-5000S-USB-GE2, ART, DEG F |
| 00834098003021 | TAT-2000C Temporal Scanner w/Safetyscan Caps |
| 10834098000577 | TAT-5000S-RS232-MUSB Oral Calibration - Celcius |
| 10834098000560 | TAT-5000S-RS232-MUSB Arterial Calibration - Celcius |
| 10834098000553 | TAT-5000S-RS232-MUSB Oral Calibration - Fahrenheit |
| 10834098000546 | TAT-5000S-RS232-MUSB Arterial Calibration - Fahrenheit |
| 10834098000881 | TAT-5000S-US Quick Release Oral Calibration |
| 10834098000874 | TAT-5000S-US Quick Release Arterial Calibration |
| 10834098000867 | TAT-5000S-US Oral Calibration |
| 10834098000850 | TAT-5000S-US Arterial Calibration |
| 10834098000621 | TAT-5000S-USB-GE2, ORAL, DEG F |
| 10834098000614 | TAT-5000S-USB-GE2, ORAL, DEG C |
| 10834098000607 | TAT-5000S-USB-GE2, ART, DEG F |