| Primary Device ID | 04035479092443 |
| NIH Device Record Key | e96b251a-c2cd-4903-a84e-8bf751f8ff1b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PK-141/2.8m |
| Version Model Number | 353181 |
| Catalog Number | 353181 |
| 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 | |
| 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 |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04035479092443 [Primary] |
| DTC | ANALYZER, PACEMAKER GENERATOR FUNCTION |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[04035479092443]
Moist Heat or Steam Sterilization
[04035479092443]
Moist Heat or Steam Sterilization
[04035479092443]
Moist Heat or Steam Sterilization
[04035479092443]
Moist Heat or Steam Sterilization
[04035479092443]
Moist Heat or Steam Sterilization
[04035479092443]
Moist Heat or Steam Sterilization
[04035479092443]
Moist Heat or Steam Sterilization
[04035479092443]
Moist Heat or Steam Sterilization
[04035479092443]
Moist Heat or Steam Sterilization
[04035479092443]
Moist Heat or Steam Sterilization
[04035479092443]
Moist Heat or Steam Sterilization
[04035479092443]
Moist Heat or Steam Sterilization
[04035479092443]
Moist Heat or Steam Sterilization
[04035479092443]
Moist Heat or Steam Sterilization
[04035479092443]
Moist Heat or Steam Sterilization
[04035479092443]
Moist Heat or Steam Sterilization
[04035479092443]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-05-14 |
| Device Publish Date | 2021-05-06 |
| 04035479188399 - NEO 2401.U/1 | 2024-12-26 |
| 04035479001575 - M-50 | 2024-10-24 |
| 04035479176143 - Home Monitoring Service Center | 2024-09-30 |
| 04035479184636 - Home Monitoring Service Center | 2024-09-23 |
| 04035479187163 - Home Monitoring Service Center | 2024-09-11 |
| 04035479186005 - NEO | 2024-06-25 |
| 04035479186012 - PSW | 2024-06-25 |
| 04035479052515 - PK-222 US/2,8m | 2024-06-06 |