Primary Device ID | 04035479188399 |
NIH Device Record Key | 1056b3b0-c736-402f-84fc-cf0db61fee8b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | NEO 2401.U/1 |
Version Model Number | 492817 |
Catalog Number | 492817 |
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 | false |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
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 | |
Phone | +1(888)345-0374 |
jon.brumbaugh@biotronik.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04035479188399 [Primary] |
OSR | Pacemaker/icd/crt non-implanted components |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-12-26 |
Device Publish Date | 2024-12-18 |
04035479188399 - NEO 2401.U/1 | 2024-12-26 |
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 |