BIOTRONIK 403724
GUDID 04035479140748
BIOTRONIK SE & Co. KG
Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Cardiac pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug Implantable pulse generator port plug| Primary Device ID | 04035479140748 |
| NIH Device Record Key | 02f8e738-bd25-4502-8e86-216220a08a1b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BIOTRONIK |
| Version Model Number | BS IS4 |
| Catalog Number | 403724 |
| Company DUNS | 315620229 |
| Company Name | BIOTRONIK SE & Co. KG |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| 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 |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04035479140748 [Package] Contains: 04035479145316 Package: case [5 Units] In Commercial Distribution |
| GS1 | 04035479145316 [Primary] |
FDA Product Code
| NIK | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-10-28 |
| Device Publish Date | 2017-08-01 |
On-Brand Devices [BIOTRONIK]
| 04035479140748 | BS IS4 |
| 04035479140755 | BS IS4 |
| 04035479177416 | MyHomeStream 2100.U |
| 04035479177409 | HomeStreamCP 2100.U |
| 04035479170356 | Resilience 55TR |
| 04035479170349 | Resilience 75TR |
| 04035479170332 | Resilience 55 |
| 04035479170325 | Resilience 75 |
| 04035479184315 | SCS PP |
| 04035479170301 | Tunneler |
| 04035479170288 | SCS NDL L |
| 04035479184322 | SCS Anchor |
| 04035479170257 | SCS Resilience Acc |
| 04035479170165 | Prospera IOC |
| 04035479170158 | Prospera Trial Acc |
| 04035479170141 | Neuro M50 |
| 04035479170127 | Prospera EPG |
| 04035479170110 | Prospera IPG |
| 04035479170103 | Prospera CHG |
| 04035479166120 | BIOwand |
| 04035479177850 | BIOMONITOR IV |
| 04035479174040 | Amvia Sky HF-T QP |
| 04035479174033 | Amvia Sky HF-T |
| 04035479174026 | Amvia Sky DR-T |
| 04035479174019 | Amvia Sky SR-T |
| 04035479174002 | Amvia Edge HF-T QP |
| 04035479173999 | Amvia Edge DR-T |
| 04035479173982 | Amvia Edge SR-T |
| 04035479173944 | Solvia Rise DR-T |
| 04035479173937 | Solvia Rise SR-T |
| 04035479182977 | PSW 2302.U |
| 04035479182960 | NEO 2302.U |
| 04035479184575 | TrueLock |
Trademark Results [BIOTRONIK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOTRONIK 79322962 not registered Live/Pending |
BIOTRONIK SE & Co. KG 2021-06-07 |
 BIOTRONIK 73574440 1403015 Live/Registered |
BIOTRONIK SALES, INC. 1985-12-20 |
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