Primary Device ID | 04035479009335 |
NIH Device Record Key | d1046b16-564b-4a6d-a09f-57d0385b35d6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PA-2 |
Version Model Number | 123157 |
Catalog Number | 123157 |
Company DUNS | 315620229 |
Company Name | BIOTRONIK SE & Co. KG |
Device Count | 1 |
DM Exempt | true |
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 |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04035479009335 [Primary] |
KRG | Programmer, pacemaker |
Steralize Prior To Use | true |
Device Is Sterile | true |
[04035479009335]
Moist Heat or Steam Sterilization
[04035479009335]
Moist Heat or Steam Sterilization
[04035479009335]
Moist Heat or Steam Sterilization
[04035479009335]
Moist Heat or Steam Sterilization
[04035479009335]
Moist Heat or Steam Sterilization
[04035479009335]
Moist Heat or Steam Sterilization
[04035479009335]
Moist Heat or Steam Sterilization
[04035479009335]
Moist Heat or Steam Sterilization
[04035479009335]
Moist Heat or Steam Sterilization
[04035479009335]
Moist Heat or Steam Sterilization
[04035479009335]
Moist Heat or Steam Sterilization
[04035479009335]
Moist Heat or Steam Sterilization
[04035479009335]
Moist Heat or Steam Sterilization
[04035479009335]
Moist Heat or Steam Sterilization
[04035479009335]
Moist Heat or Steam Sterilization
[04035479009335]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2021-05-26 |
Device Publish Date | 2014-08-25 |
04035479186005 - NEO | 2024-06-25 |
04035479186012 - PSW | 2024-06-25 |
04035479052515 - PK-222 US/2,8m | 2024-06-06 |
04035479186128 - Home Monitoring Service Center | 2024-06-06 |
04035479184575 - BIOTRONIK | 2024-02-28 |
04035479116644 - Selectra | 2024-01-25 |
04035479184285 - NEO | 2023-12-25 |
04035479184292 - PSW | 2023-12-25 |