Reliaty 365530
GUDID 04035479110062
BIOTRONIK SE & Co. KG
Implantable pacemaker analyser, intraoperative Implantable pacemaker analyser, intraoperative Implantable pacemaker analyser, intraoperative Implantable pacemaker analyser, intraoperative Implantable pacemaker analyser, intraoperative Implantable pacemaker analyser, intraoperative Implantable pacemaker analyser, intraoperative Implantable pacemaker analyser, intraoperative Implantable pacemaker analyser, intraoperative Implantable pacemaker analyser, intraoperative Implantable pacemaker analyser, intraoperative Implantable pacemaker analyser, intraoperative Implantable pacemaker analyser, intraoperative Implantable pacemaker analyser, intraoperative Implantable pacemaker analyser, intraoperative| Primary Device ID | 04035479110062 |
| NIH Device Record Key | e2de9b16-62b1-46c9-b357-d8883defa547 |
| Commercial Distribution Discontinuation | 2022-10-05 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Reliaty |
| Version Model Number | 365530 |
| Catalog Number | 365530 |
| Company DUNS | 315620229 |
| Company Name | BIOTRONIK SE & Co. KG |
| 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 | false |
| 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(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com | |
| Phone | +1(888)345-0374 |
| jon.brumbaugh@biotronik.com |
Operating and Storage Conditions
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04035479110062 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P950037
FDA Product Code
| OVJ | Pulse generator, external pacemaker, dual-chamber |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2022-10-06 |
| Device Publish Date | 2014-08-08 |
Devices Manufactured by BIOTRONIK SE & Co. KG
| 04035479184575 - BIOTRONIK | 2024-02-28 |
| 04035479116644 - Selectra | 2024-01-25 |
| 04035479184285 - NEO | 2023-12-25 |
| 04035479184292 - PSW | 2023-12-25 |
| 04035479185510 - Renamic Neo NEOexpress | 2023-12-25 |
| 04035479183264 - Home Monitoring Service Center | 2023-10-23 |
| 04035479100650 - S 60-C | 2023-10-09 |
| 04035479011864 - S 75-A | 2023-10-06 |
Trademark Results [Reliaty]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RELIATY 77678422 4033064 Live/Registered |
BIOTRONIK SE & CO. KG 2009-02-25 |
 RELIATY 76279862 2705304 Dead/Cancelled |
Workstation Solutions, Incorporated 2001-07-05 |
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