Novii
GUDID 15060433670050
Novii Interface
MONICA HEALTHCARE LIMITED
Foetal cardiac monitor| Primary Device ID | 15060433670050 |
| NIH Device Record Key | 0b662774-c719-4a46-a49a-aa430b8755ac |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Novii |
| Version Model Number | 107-PT-001 |
| Company DUNS | 346332666 |
| Company Name | MONICA HEALTHCARE LIMITED |
| 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 | false |
| Lot Batch | true |
| 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 | +1 877-320-5174 |
| info@monicahealthcare.com | |
| Phone | +1 877-320-5174 |
| info@monicahealthcare.com | |
| Phone | +1 877-320-5174 |
| info@monicahealthcare.com | |
| Phone | +1 877-320-5174 |
| info@monicahealthcare.com | |
| Phone | +1 877-320-5174 |
| info@monicahealthcare.com | |
| Phone | +1 877-320-5174 |
| info@monicahealthcare.com | |
| Phone | +1 877-320-5174 |
| info@monicahealthcare.com | |
| Phone | +1 877-320-5174 |
| info@monicahealthcare.com | |
| Phone | +1 877-320-5174 |
| info@monicahealthcare.com | |
| Phone | +1 877-320-5174 |
| info@monicahealthcare.com | |
| Phone | +1 877-320-5174 |
| info@monicahealthcare.com | |
| Phone | +1 877-320-5174 |
| info@monicahealthcare.com | |
| Phone | +1 877-320-5174 |
| info@monicahealthcare.com | |
| Phone | +1 877-320-5174 |
| info@monicahealthcare.com | |
| Phone | +1 877-320-5174 |
| info@monicahealthcare.com |
Operating and Storage Conditions
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060433670053 [Primary] |
| GS1 | 15060433670050 [Package] Contains: 05060433670053 Package: Box [1 Units] In Commercial Distribution |
FDA Product Code
| OSP | Uterine Electromyographic Monitor |
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 | 2018-09-25 |
| Device Publish Date | 2016-09-12 |
On-Brand Devices [Novii]
| 15060433670241 | Novii Interface Power Supply |
| 35060433670061 | Novii Pod |
| 15060433670050 | Novii Interface |
| 05060433670015 | Novii Wireless Patch System (GEHC) |
| 35060433670078 | Novii Patch |
| 00840682142731 | POD 107-PT-003 |
| 00840682142700 | Interface 107-PT-001 |
Trademark Results [Novii]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NOVII 98150258 not registered Live/Pending |
Rolnitzky, Shimon 2023-08-25 |
 NOVII 88552642 not registered Live/Pending |
Meng Xianghu 2019-07-31 |
 NOVII 79156457 4861475 Live/Registered |
Monica Healthcare Limited 2014-07-01 |
 NOVII 78136366 2851885 Dead/Cancelled |
Novii Technology Solutions, Inc. 2002-06-17 |
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