CapSure Sense®
GUDID 00643169410831
LEAD 457453 US BI RCMCRD
MEDTRONIC, INC.
Endocardial pacing lead| Primary Device ID | 00643169410831 |
| NIH Device Record Key | 2b2d300b-09b6-4c3f-9404-264a8740b5b1 |
| Commercial Distribution Discontinuation | 2019-02-25 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | CapSure Sense® |
| Version Model Number | 457453 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| 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 | true |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| 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 |
Customer Support Contacts
Device Dimensions
| Length | 53 Centimeter |
| Length | 53 Centimeter |
| Length | 53 Centimeter |
| Length | 53 Centimeter |
| Length | 53 Centimeter |
| Length | 53 Centimeter |
| Length | 53 Centimeter |
| Length | 53 Centimeter |
| Length | 53 Centimeter |
| Length | 53 Centimeter |
| Length | 53 Centimeter |
| Length | 53 Centimeter |
| Length | 53 Centimeter |
| Length | 53 Centimeter |
| Length | 53 Centimeter |
| Length | 53 Centimeter |
| Length | 53 Centimeter |
| Length | 53 Centimeter |
| Length | 53 Centimeter |
| Length | 53 Centimeter |
| Length | 53 Centimeter |
| Length | 53 Centimeter |
| Length | 53 Centimeter |
| Length | 53 Centimeter |
| Length | 53 Centimeter |
| Length | 53 Centimeter |
| Length | 53 Centimeter |
| Length | 53 Centimeter |
| Length | 53 Centimeter |
| Length | 53 Centimeter |
Operating and Storage Conditions
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169410831 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P830061
FDA Product Code
| DTB | permanent pacemaker Electrode |
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 | 2019-03-05 |
| Device Publish Date | 2014-11-04 |
On-Brand Devices [CapSure Sense®]
| 00643169590540 | LEAD 407485 CAPSURE SENSE US BI RCMCRD |
| 00643169590533 | LEAD 407465 CAPSURE SENSE US BI RCMCRD |
| 00643169590526 | LEAD 407458 CAPSURE SENSE US BI RCMCRD |
| 00643169590519 | LEAD 407452 CAPSURE SENSE US BI RCMCRD |
| 00643169590502 | LEAD 407445 CAPSURE SENSE US BI RCMCRD |
| 00643169590496 | LEAD 407365 US UNI RCMCRD |
| 00643169590489 | LEAD 407345 US UNI RCMCRD |
| 00643169590472 | LEAD 407358 US UNI RCMCRD |
| 00643169590465 | LEAD 407352 US UNI RCMCRD |
| 00643169411104 | LEAD 407485 US BI RCMCRD |
| 00643169411098 | LEAD 407465 US BI RCMCRD |
| 00643169411081 | LEAD 407458 US BI RCMCRD |
| 00643169411074 | LEAD 407452 US BI RCMCRD |
| 00643169411067 | LEAD 407445 US BI RCMCRD |
| 00643169411029 | LEAD 407358 US UNI RCMCRD |
| 00643169411012 | LEAD 407352 US UNI RCMCRD |
| 00643169410985 | LEAD 407365 US UNI RCMCRD |
| 00643169410978 | LEAD 407345 US UNI RCMCRD |
| 00643169410831 | LEAD 457453 US BI RCMCRD |
| 00643169410824 | LEAD 457445 US BI RCMCRD |
Trademark Results [CapSure Sense]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CAPSURE SENSE 78122837 2851852 Live/Registered |
MEDTRONIC INC. 2002-04-19 |
 CAPSURE SENSE 78065698 not registered Dead/Abandoned |
MEDTRONIC, INC. 2001-05-25 |
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