NEUROVENT
GUDID 04057834026146
RAUMEDIC AG
Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter, short-term Intracerebral sensor catheter, short-term Intracerebral sensor catheter, short-term Intracerebral sensor catheter, short-term Intracerebral sensor catheter, short-term Intracerebral sensor catheter, short-term| Primary Device ID | 04057834026146 |
| NIH Device Record Key | e9fc8dea-ef7c-4bec-828d-d1299abe9e17 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NEUROVENT |
| Version Model Number | 092956-002 |
| Company DUNS | 332785323 |
| Company Name | RAUMEDIC AG |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| 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 | 8886470070 |
| hospitalcare@raumedic.com | |
| Phone | 8886470070 |
| hospitalcare@raumedic.com | |
| Phone | 8886470070 |
| hospitalcare@raumedic.com | |
| Phone | 8886470070 |
| hospitalcare@raumedic.com | |
| Phone | 8886470070 |
| hospitalcare@raumedic.com | |
| Phone | 8886470070 |
| hospitalcare@raumedic.com | |
| Phone | 8886470070 |
| hospitalcare@raumedic.com | |
| Phone | 8886470070 |
| hospitalcare@raumedic.com | |
| Phone | 8886470070 |
| hospitalcare@raumedic.com | |
| Phone | 8886470070 |
| hospitalcare@raumedic.com | |
| Phone | 8886470070 |
| hospitalcare@raumedic.com | |
| Phone | 8886470070 |
| hospitalcare@raumedic.com | |
| Phone | 8886470070 |
| hospitalcare@raumedic.com | |
| Phone | 8886470070 |
| hospitalcare@raumedic.com | |
| Phone | 8886470070 |
| hospitalcare@raumedic.com | |
| Phone | 8886470070 |
| hospitalcare@raumedic.com | |
| Phone | 8886470070 |
| hospitalcare@raumedic.com | |
| Phone | 8886470070 |
| hospitalcare@raumedic.com | |
| Phone | 8886470070 |
| hospitalcare@raumedic.com | |
| Phone | 8886470070 |
| hospitalcare@raumedic.com | |
| Phone | 8886470070 |
| hospitalcare@raumedic.com | |
| Phone | 8886470070 |
| hospitalcare@raumedic.com |
Device Dimensions
| Outer Diameter | 3.1 Millimeter |
| Outer Diameter | 3.1 Millimeter |
| Outer Diameter | 3.1 Millimeter |
| Outer Diameter | 3.1 Millimeter |
| Outer Diameter | 3.1 Millimeter |
| Outer Diameter | 3.1 Millimeter |
| Outer Diameter | 3.1 Millimeter |
| Outer Diameter | 3.1 Millimeter |
| Outer Diameter | 3.1 Millimeter |
| Outer Diameter | 3.1 Millimeter |
| Outer Diameter | 3.1 Millimeter |
| Outer Diameter | 3.1 Millimeter |
| Outer Diameter | 3.1 Millimeter |
| Outer Diameter | 3.1 Millimeter |
| Outer Diameter | 3.1 Millimeter |
| Outer Diameter | 3.1 Millimeter |
| Outer Diameter | 3.1 Millimeter |
| Outer Diameter | 3.1 Millimeter |
| Outer Diameter | 3.1 Millimeter |
| Outer Diameter | 3.1 Millimeter |
| Outer Diameter | 3.1 Millimeter |
| Outer Diameter | 3.1 Millimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04057834026146 [Primary] |
FDA Product Code
| GWM | Device, Monitoring, Intracranial Pressure |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-08-18 |
Devices Manufactured by RAUMEDIC AG
| 04057834099010 - NPS2 GE | 2021-10-19 |
| 04057834084054 - Wide range power adapter MPR 1/2 | 2021-05-18 |
| 04057834029215 - EASY logO | 2020-05-06 |
| 04057834073393 - EASY logO | 2020-05-06 |
| 04057834073591 - MPR2 logO DATALOGGER | 2020-05-06 |
| 04057834073430 - Stand Holder DATALOGGER | 2019-06-07 |
| 04057834073454 - Table Stand DATALOGGER | 2019-03-07 |
| 04057834083439 - NPS2 Tempus Pro | 2018-12-14 |
Trademark Results [NEUROVENT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEUROVENT 79107714 4252135 Live/Registered |
RAUMEDIC AG 2011-11-24 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.