BIOMONITOR 436066
GUDID 04035479158453
BIOTRONIK SE & Co. KG
Implantable cardiac monitor| Primary Device ID | 04035479158453 |
| NIH Device Record Key | 41606cbe-0d60-4273-8bb4-ad9446bd7fe7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BIOMONITOR |
| Version Model Number | III |
| Catalog Number | 436066 |
| 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 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04035479158453 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K190548
FDA Product Code
| MXD | RECORDER,EVENT,IMPLANTABLE CARDIAC,(WITH ARRHYTHMIA DETECTION) |
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 | 2020-05-07 |
| Device Publish Date | 2019-07-10 |
On-Brand Devices [BIOMONITOR]
| 04035479158453 | III |
| 04035479135539 | 2-S |
| 04035479135522 | 2-AF |
| 04035479131210 | 394119 |
| 04035479144227 | Remote Assistant |
| 04035479169862 | IIIm |
| 04035479149314 | FIT-Fast Insert Tool 1 + 2, Set |
Trademark Results [BIOMONITOR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOMONITOR 86538311 5046341 Live/Registered |
BIOTRONIK SE & Co. KG 2015-02-18 |
 BIOMONITOR 79053841 3746900 Dead/Cancelled |
BIOTRONIK SE & Co. KG 2008-01-30 |
 BIOMONITOR 79047745 3647657 Dead/Cancelled |
BIOTRONIK SE & Co. KG 2007-11-01 |
 BIOMONITOR 78214992 2940748 Dead/Cancelled |
Applera Corporation 2003-02-14 |
 BIOMONITOR 73014956 1016744 Dead/Expired |
BIOCONTROL COMPANY 1974-03-04 |
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