Primary Device ID | 04035479002916 |
NIH Device Record Key | a8c9ebc1-48a6-4484-ba36-14629f5c85df |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | EFH-16 |
Version Model Number | 115489 |
Catalog Number | 115489 |
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 | 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 | |
Phone | +1(888)345-0374 |
jon.brumbaugh@biotronik.com |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Special Storage Condition, Specify | Between 0 and 0 |
Storage Environment Temperature | Between 41 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04035479002916 [Package] Contains: 04035479144821 Package: case [10 Units] In Commercial Distribution |
GS1 | 04035479144821 [Primary] |
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 | 2019-10-28 |
Device Publish Date | 2014-08-14 |
04035479184575 - BIOTRONIK | 2024-02-28 |
04035479116644 - Selectra | 2024-01-25 |
04035479184285 - NEO | 2023-12-25 |
04035479184292 - PSW | 2023-12-25 |
04035479185510 - Renamic Neo NEOexpress | 2023-12-25 |
04035479183264 - Home Monitoring Service Center | 2023-10-23 |
04035479100650 - S 60-C | 2023-10-09 |
04035479011864 - S 75-A | 2023-10-06 |