Primary Device ID | 00816271020094 |
NIH Device Record Key | d06d7b01-812d-4e5d-9556-040a3a09e4dc |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Telemyo |
Version Model Number | 546 |
Company DUNS | 611243809 |
Company Name | Noraxon U.S.A., Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | 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 | false |
Phone | 4804433413 |
noraxon@noraxon.com | |
Phone | 4804433413 |
noraxon@noraxon.com | |
Phone | 4804433413 |
noraxon@noraxon.com | |
Phone | 4804433413 |
noraxon@noraxon.com | |
Phone | 4804433413 |
noraxon@noraxon.com | |
Phone | 4804433413 |
noraxon@noraxon.com | |
Phone | 4804433413 |
noraxon@noraxon.com | |
Phone | 4804433413 |
noraxon@noraxon.com | |
Phone | 4804433413 |
noraxon@noraxon.com | |
Phone | 4804433413 |
noraxon@noraxon.com | |
Phone | 4804433413 |
noraxon@noraxon.com | |
Phone | 4804433413 |
noraxon@noraxon.com | |
Phone | 4804433413 |
noraxon@noraxon.com | |
Phone | 4804433413 |
noraxon@noraxon.com | |
Phone | 4804433413 |
noraxon@noraxon.com | |
Phone | 4804433413 |
noraxon@noraxon.com | |
Phone | 4804433413 |
noraxon@noraxon.com | |
Phone | 4804433413 |
noraxon@noraxon.com | |
Phone | 4804433413 |
noraxon@noraxon.com | |
Phone | 4804433413 |
noraxon@noraxon.com | |
Phone | 4804433413 |
noraxon@noraxon.com |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00816271020094 [Primary] |
HCC | Device, Biofeedback |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2017-02-13 |
00816271020155 | Telemyo DTS Desktop Receiver (W/O Analog Out) |
00816271020148 | Telemyo Mini Receiver |
00816271020131 | Telemyo Clinical DTS Receiver |
00816271020124 | Telemyo DTS Desktop Receiver |
00816271020117 | Telemyo DTS Belt Receiver |
00816271020100 | Telemyo Research DTS EMG Lossless |
00816271020094 | Telemyo Clinical DTS EMG |
00816271020087 | Telemyo DTS EMG |
00816271020063 | TeleMyo Sensor Charger |
00816271020056 | Telemyo PC-Interface |
00816271020049 | Telemyo 2400T G2 |
00816271020292 | Telemyo Research DTS EMG |
00816271020858 | Telemyo 2400 G2 Transmitter |
00816271020070 | Telemyo 2400R G2 Analog Output Receiver |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TELEMYO 78633610 3331041 Dead/Cancelled |
Noraxon USA, Inc. 2005-05-19 |