OBIX OBIX IN2 Z B-BIO
GUDID 05051968047151
OBIX INTRAPARTUM/NIBP+SPO2+EMHR-TWIN+BATTERY MASIMO - BIOMED
HUNTLEIGH HEALTHCARE LIMITED
Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor Foetal/maternal prenatal monitor| 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 |
Customer Support Contacts
Operating and Storage Conditions
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05051968047151 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K200975
FDA Product Code
| HGM | System, Monitoring, Perinatal |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-22 |
| Device Publish Date | 2024-05-14 |
On-Brand Devices [OBIX]
| 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 |
Trademark Results [OBIX]
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.