SONICAID ACC-OBS-009L
GUDID 05051968029836
SONCD FM800 ENCOR EXT TOCO TDR-3M
HUNTLEIGH HEALTHCARE LIMITED
Cardiotocograph transducer| Primary Device ID | 05051968029836 |
| NIH Device Record Key | d16d8343-852c-4f6a-8630-3e1c07a7d988 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SONICAID |
| Version Model Number | ACC-OBS-009L |
| Catalog Number | ACC-OBS-009L |
| Company DUNS | 217207083 |
| Company Name | HUNTLEIGH HEALTHCARE LIMITED |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +4402920485885 |
| sales@huntleigh-diagnostics.co | |
| Phone | +4402920485885 |
| sales@huntleigh-diagnostics.co.uk | |
| Phone | +4402920485885 |
| sales@huntleigh-diagnostics.co.uk | |
| Phone | +4402920485885 |
| sales@huntleigh-diagnostics.co.uk | |
| Phone | +4402920485885 |
| sales@huntleigh-diagnostics.co.uk | |
| Phone | +4402920485885 |
| sales@huntleigh-diagnostics.co.uk | |
| Phone | +4402920485885 |
| sales@huntleigh-diagnostics.co.uk | |
| Phone | +4402920485885 |
| sales@huntleigh-diagnostics.co.uk | |
| Phone | +4402920485885 |
| sales@huntleigh-diagnostics.co.uk | |
| Phone | +4402920485885 |
| sales@huntleigh-diagnostics.co.uk | |
| Phone | +4402920485885 |
| sales@huntleigh-diagnostics.co.uk | |
| Phone | +4402920485885 |
| sales@huntleigh-diagnostics.co.uk |
Operating and Storage Conditions
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 680 millibar and 1060 millibar |
| Storage Environment Atmospheric Pressure | Between 680 millibar and 1060 millibar |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 680 millibar and 1060 millibar |
| Storage Environment Atmospheric Pressure | Between 680 millibar and 1060 millibar |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 680 millibar and 1060 millibar |
| Storage Environment Atmospheric Pressure | Between 680 millibar and 1060 millibar |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 680 millibar and 1060 millibar |
| Storage Environment Atmospheric Pressure | Between 680 millibar and 1060 millibar |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 680 millibar and 1060 millibar |
| Storage Environment Atmospheric Pressure | Between 680 millibar and 1060 millibar |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 680 millibar and 1060 millibar |
| Storage Environment Atmospheric Pressure | Between 680 millibar and 1060 millibar |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 680 millibar and 1060 millibar |
| Storage Environment Atmospheric Pressure | Between 680 millibar and 1060 millibar |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 680 millibar and 1060 millibar |
| Storage Environment Atmospheric Pressure | Between 680 millibar and 1060 millibar |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 680 millibar and 1060 millibar |
| Storage Environment Atmospheric Pressure | Between 680 millibar and 1060 millibar |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 680 millibar and 1060 millibar |
| Storage Environment Atmospheric Pressure | Between 680 millibar and 1060 millibar |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 680 millibar and 1060 millibar |
| Storage Environment Atmospheric Pressure | Between 680 millibar and 1060 millibar |
| Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 680 millibar and 1060 millibar |
| Storage Environment Atmospheric Pressure | Between 680 millibar and 1060 millibar |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05051968029836 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K090285
FDA Product Code
| HGM | System, Monitoring, Perinatal |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-12 |
On-Brand Devices [SONICAID]
| 05051968032713 | ELASTIC BELT (LATEX FREE)PAIR |
| 05051968032140 | 1.5Mhz ULTRASOUND TRANSDUCER 3MTR |
| 05051968029843 | SONCD FM800 ENCOR EXT U/S TDR-2M |
| 05051968029836 | SONCD FM800 ENCOR EXT TOCO TDR-3M |
| 05051968029829 | SONCD FM800 ENCOR EXT TOCO TDR-2M |
| 05051968008237 | 1.5Mhz ULTRASOUND TRANSDUCER |
| 05051968032416 | FREEDOM TOCO TDR |
| 05051968032409 | FREEDOM US TDR (WMTS) |
| 05051968032133 | SONICAID FREEDOM WMTS |
| 05051968041418 | USA DIG DOPPLER-FIXED 3MHZ PROBE |
| 05051968041401 | USA DIG DOPPLER-FIXED 2MHZ PROBE |
| 05051968041395 | USA DIG DOPPLER-ALKALINE-NO PROBE |
| 05051968044037 | TEAM3 ANTEPARTUM/ECTG+NIBP+BATTERY USA |
| 05051968044020 | TEAM3 ANTEPARTUM/ECTG+NIBP USA |
| 05051968032522 | TEAM3 ANTEPARTUM/PRINTER+NIBP USA |
| 05051968032515 | TEAM3 ANTEPARTUM/ECTG+BATTERY USA |
| 05051968032508 | TEAM3 ANTEPARTUM/ECTG USA |
| 05051968032492 | TEAM3 ANTEPARTUM/PRINTER+BATTERY USA |
| 05051968032485 | TEAM3 ANTEPARTUM/PRINTER USA |
| 00505196832539 | TEAM3 ANTEPARTUM/PRINTER+NIBP+BATTERY USA |
| 05051968032539 | TEAM3 ANTEPARTUM/PRINTER+NIBP+BATTERY USA |
| 05051968044310 | TEAM3 ANTEPARTUM/PRINTER+NIBP+BATTERY USA |
| 05051968044303 | TEAM3 ANTEPARTUM/PRINTER+NIBP USA |
| 05051968044297 | TEAM3 ANTEPARTUM/ECTG+NIBP+BATTERY USA |
| 05051968044280 | TEAM3 ANTEPARTUM/ECTG+NIBP USA |
| 05051968044273 | TEAM3 ANTEPARTUM/ECTG+BATTERY USA |
| 05051968044266 | TEAM3 ANTEPARTUM/ECTG USA |
| 05051968044259 | TEAM3 ANTEPARTUM/PRINTER+BATTERY USA |
| 05051968044242 | TEAM3 ANTEPARTUM/PRINTER USA |
Trademark Results [SONICAID]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SONICAID 73025664 1040558 Live/Registered |
SONICAID LIMITED 1974-06-28 |
 SONICAID 73025661 1038149 Live/Registered |
SONICAID LIMITED 1974-06-28 |
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