SONICAID ACC-MI1136
GUDID 05051968032713
ELASTIC BELT (LATEX FREE)PAIR
HUNTLEIGH HEALTHCARE LIMITED
Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable Personal device holder, reusable| Primary Device ID | 05051968032713 |
| NIH Device Record Key | dee9195e-f839-4db8-952e-49f9ac20967f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SONICAID |
| Version Model Number | ACC-MI1136 |
| Catalog Number | ACC-MI1136 |
| 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 | true |
| Serial Number | false |
| 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
Operating and Storage Conditions
| Storage Environment Atmospheric Pressure | Between 680 millibar and 1060 millibar |
| Storage Environment Atmospheric Pressure | Between 680 millibar and 1060 millibar |
| Storage Environment Atmospheric Pressure | Between 680 millibar and 1060 millibar |
| Storage Environment Atmospheric Pressure | Between 680 millibar and 1060 millibar |
| Storage 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 |
| 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 |
| 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 | 05051968032713 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K912639
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 | 5 |
| Public Version Date | 2019-12-11 |
| Device Publish Date | 2016-09-19 |
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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