Primary Device ID | 04035479006211 |
NIH Device Record Key | 73cb08eb-4af5-4c90-85c7-d1f22672a877 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | EFH-30 |
Version Model Number | 119964 |
Catalog Number | 119964 |
Company DUNS | 315620229 |
Company Name | BIOTRONIK SE & Co. KG |
Device Count | 3 |
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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains 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 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04035479006211 [Package] Contains: 04035479144890 Package: case [10 Units] In Commercial Distribution |
GS1 | 04035479144890 [Primary] |
GS1 | 04035479147051 [Unit of Use] |
DTB | permanent pacemaker Electrode |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2021-02-19 |
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 |