Primary Device ID | 04035479017279 |
NIH Device Record Key | 3057059c-1ca0-4c32-8b4e-d0028a9fa060 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PK-83/2,5m |
Version Model Number | 128563 |
Catalog Number | 128563 |
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 |
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04035479017279 [Primary] |
KRG | Programmer, pacemaker |
Steralize Prior To Use | true |
Device Is Sterile | true |
[04035479017279]
Moist Heat or Steam Sterilization
[04035479017279]
Moist Heat or Steam Sterilization
[04035479017279]
Moist Heat or Steam Sterilization
[04035479017279]
Moist Heat or Steam Sterilization
[04035479017279]
Moist Heat or Steam Sterilization
[04035479017279]
Moist Heat or Steam Sterilization
[04035479017279]
Moist Heat or Steam Sterilization
[04035479017279]
Moist Heat or Steam Sterilization
[04035479017279]
Moist Heat or Steam Sterilization
[04035479017279]
Moist Heat or Steam Sterilization
[04035479017279]
Moist Heat or Steam Sterilization
[04035479017279]
Moist Heat or Steam Sterilization
[04035479017279]
Moist Heat or Steam Sterilization
[04035479017279]
Moist Heat or Steam Sterilization
[04035479017279]
Moist Heat or Steam Sterilization
[04035479017279]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2021-05-27 |
Device Publish Date | 2014-08-19 |
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