Primary Device ID | 05051968047151 |
NIH Device Record Key | 7f0b4626-066e-40d2-a05d-4384e9c034f4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | OBIX |
Version Model Number | OBIX IN2 Z B-BIO |
Catalog Number | OBIX IN2 Z B-BIO |
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 |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 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 700 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 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 700 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 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 700 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 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 700 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 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 700 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 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 700 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 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 700 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 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 700 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 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 700 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 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 700 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 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 700 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 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 700 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 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 700 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 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 700 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 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 700 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 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 700 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 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 700 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 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 700 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05051968047151 [Primary] |
HGM | System, Monitoring, Perinatal |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-05-22 |
Device Publish Date | 2024-05-14 |
05051968042057 | OBIX FREEDOM |
05051968041234 | OBIX INTRAPARTUM/NIBP+SPO2+EMHR-TWIN |
05051968042071 | OBIX ANTEPARTUM-TWIN |
05051968042972 | OBIX INTRAPARTUM/NIBP+SPO2+EMHR+DVI TWINS |
05051968047045 | OBIX ANTEPARTUM-TWIN MASIMO |
05051968047038 | OBIX INTRAPARTUM/NIBP+SPO2+EMHR-TWIN+BATTERY MASIMO |
05051968047021 | OBIX INTRAPARTUM/NIBP+SPO2+EMHR-TWIN MASIMO |
05051968047144 | OBIX ANTEPARTUM/NIBP+MASIMO SPO2+BATTERY-TWINS |
05051968047151 | OBIX INTRAPARTUM/NIBP+SPO2+EMHR-TWIN+BATTERY MASIMO - BIOMED |
05051968047090 | OBIX ANTEPARTUM/NIBP+NELL/TWIN |
05051968047120 | OBIX INTRAPARTUM/NIBP+SPO2+EMHR-TWIN MASIMO BIOMED |
05051968047113 | OBIX INTRAPARTUM/NIBP+NELL-TWIN-BIOMED |
05051968047106 | OBIX INTRAPARTUM/NIBP+NELL-TWIN |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
OBIX 88373431 not registered Live/Pending |
Clinical Computer Systems, Inc. 2019-04-05 |
OBIX 78053868 not registered Dead/Abandoned |
Kabbani, Najib 2001-03-19 |
OBIX 76521991 3006906 Live/Registered |
Clinical Computer Systems, Inc. 2003-06-11 |
OBIX 76521990 2915648 Dead/Cancelled |
Clinical Computer Systems, Inc. 2003-06-11 |