Capsure® EPI
GUDID 00613994501776
LEAD 4965-35 US UNI EPI STERD 35CM
MEDTRONIC, INC.
Epicardial pacing lead| Primary Device ID | 00613994501776 |
| NIH Device Record Key | 0192c0de-3afa-482c-bcf9-b360e83a0a34 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Capsure® EPI |
| Version Model Number | 4965-35 |
| 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 | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 Centimeter |
| Length | 35 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 | 00613994501776 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P950024
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 | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2014-09-23 |
On-Brand Devices [Capsure® EPI]
| 00613994501813 | LEAD 4965-50 US UNI EPI STEROID 50CM |
| 00613994501776 | LEAD 4965-35 US UNI EPI STERD 35CM |
| 00613994501745 | LEAD 4965-25 US UNI EPI STERD 25CM |
| 00613994501721 | LEAD 4965-15 US UNI EPI STEROID 15CM |
| 00613994492340 | LEAD 4968-60 US BIPOLAR EPICARDIAL 60CM |
| 00613994492302 | LEAD 4968-35 US BIPOLAR EPICARDIAL 35CM |
| 00613994492272 | LEAD 4968-25 US BIPOLAR EPICARDIAL 25CM |
| 00681490116725 | LEAD 4968-35 BIP EPI US |
| 00681490116503 | LEAD 4965-35 UNI EPI STEROID |
| 00681490116336 | LEAD 4965-15 CAPSURE EPI PACING US |
Trademark Results [Capsure]
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