| Primary Device ID | 00763000916633 |
| NIH Device Record Key | 72fb64dd-456a-4b40-ba88-b37b14f3e1bc |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 8596SC |
| Company DUNS | 796986144 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000916633 [Primary] |
| LKK | Pump, infusion, implanted, programmable |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-14 |
| Device Publish Date | 2024-05-06 |
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| 00199150003709 - Sphere-9™ Catheter | 2026-03-02 CATHETER AFR-00001 SPHERE 9 US GAL |
| 20763000558189 - CLOTtrac™ | 2026-03-02 CONTROL 550-01 CLOTTRAC CWB |
| 20763000558196 - CLOTtrac™ | 2026-03-02 CONTROL 550-07 CLOTTRAC HR 15BX |
| 20763000558202 - CLOTtrac™ | 2026-03-02 CONT 550-08 CLOTTRAC HR ABN BXD ASY |
| 20763000558219 - CLOTtrac™ | 2026-03-02 CONT 550-09 CLOTTRAC LR ABN BXD ASY |
| 20763000558226 - CLOTtrac™ | 2026-03-02 CONT 550-10 CLOTTRAC RACT ABN |
| 20763000558233 - CLOTtrac™ | 2026-03-02 CONTROL 550-12 CLOTTRAC HTC |