Kainox 124325
GUDID 04035479011987
BIOTRONIK SE & Co. KG
Endocardial defibrillation lead| Primary Device ID | 04035479011987 |
| NIH Device Record Key | e9c02da5-647f-42b6-9af8-74aeec7ab716 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Kainox |
| Version Model Number | VCS 60 |
| Catalog Number | 124325 |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| 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 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04035479011987 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P980023
FDA Product Code
| NVY | Permanent defibrillator electrodes |
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 | 2021-02-05 |
| Device Publish Date | 2014-08-19 |
Devices Manufactured by BIOTRONIK SE & Co. KG
| 04035479188689 - SW HMSC 3.63 | 2025-05-15 |
| 04035479179687 - NEO | 2025-04-11 |
| 04035479179694 - PSW | 2025-04-11 |
| 04035479185817 - Neuro CP app 2300.U | 2025-04-04 |
| 04035479188733 - Neuro PR app 2400.U | 2025-04-04 |
| 04035479184445 - PatientApp 2.8 | 2025-02-20 |
| 04035479187927 - SW HMSC 3.62 | 2025-01-28 |
| 04035479188399 - NEO 2401.U/1 | 2024-12-26 |
Trademark Results [Kainox]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 KAINOX 75429524 2287242 Dead/Cancelled |
BIOTRONIK Mess- und Therapiegeraete GmbH & Co. Ingenieurbuero Berlin 1998-02-05 |
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