CAPSURE® SENSE
GUDID 00885074200637
LEAD 407445 CAPSURE SENSE PACING US
MEDTRONIC, INC.
Endocardial pacing lead| Primary Device ID | 00885074200637 |
| NIH Device Record Key | 495bc81a-c9e1-4997-9192-72786844c09e |
| Commercial Distribution Discontinuation | 2018-10-10 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | CAPSURE® SENSE |
| Version Model Number | 407445 |
| 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 | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
| Length | 45 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885074200637 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P830061
FDA Product Code
| NVN | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker 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 | 2018-10-12 |
| Device Publish Date | 2014-09-23 |
On-Brand Devices [CAPSURE® SENSE]
| 00885074200958 | LEAD 457453 CAPSURE SENSE PACING US |
| 00885074200941 | LEAD 457445 CAPSURE SENSE PACING US |
| 00885074200668 | LEAD 407458 CAPSURE SENSE PACING US |
| 00885074200644 | LEAD 407452 CAPSURE SENSE PACING US |
| 00885074200637 | LEAD 407445 CAPSURE SENSE PACING US |
| 00885074200620 | LEAD 407358 CAPSURE SENSE PACING US |
| 00885074200613 | LEAD 407352 CAPSURE SENSE PACING US |
Trademark Results [CAPSURE]
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