| Primary Device ID | 04035479143541 |
| NIH Device Record Key | ee8ed5b2-db15-417b-9974-bb9bcfe92788 |
| Commercial Distribution Discontinuation | 2021-08-30 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Model 6653 |
| Version Model Number | 405231 |
| Catalog Number | 405231 |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 7-15 psi |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 7-15 psi |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 7-15 psi |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 7-15 psi |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 7-15 psi |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 7-15 psi |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 7-15 psi |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04035479143541 [Primary] |
| OVJ | Pulse generator, external pacemaker, dual-chamber |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[04035479143541]
Moist Heat or Steam Sterilization
[04035479143541]
Moist Heat or Steam Sterilization
[04035479143541]
Moist Heat or Steam Sterilization
[04035479143541]
Moist Heat or Steam Sterilization
[04035479143541]
Moist Heat or Steam Sterilization
[04035479143541]
Moist Heat or Steam Sterilization
[04035479143541]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-08-31 |
| Device Publish Date | 2015-10-01 |
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| 04035479186012 - PSW | 2024-06-25 |
| 04035479052515 - PK-222 US/2,8m | 2024-06-06 |
| 04035479186128 - Home Monitoring Service Center | 2024-06-06 |