BIOTRONIK 460159
GUDID 04035479174033
BIOTRONIK SE & Co. KG
Cardiac resynchronization therapy implantable pacemaker| Primary Device ID | 04035479174033 |
| NIH Device Record Key | 7f9bc148-eb72-4c05-a9c9-5846f75d4e2d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BIOTRONIK |
| Version Model Number | Amvia Sky HF-T |
| Catalog Number | 460159 |
| 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 | false |
| Serial Number | true |
| 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
Operating and Storage Conditions
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04035479174033 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P950037
FDA Product Code
| NKE | Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-20 |
| Device Publish Date | 2023-07-12 |
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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