| Primary Device ID | 00613994558589 |
| NIH Device Record Key | b288f3c8-2bce-4c2c-8335-ab2b73d5876c |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 3550-55 |
| Company DUNS | 796986144 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| 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 | 00613994558589 [Primary] |
| OAG | Garment, storage, peritoneal dialysis catheter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-12-11 |
| Device Publish Date | 2015-12-02 |
| 00763000661588 - Profile 3D™ | 2025-09-16 RING 680R24 PROFILE 3D MEXICO MDR |
| 00763000661595 - Profile 3D™ | 2025-09-16 RING 680R26 PROFILE 3D MEXICO MDR |
| 00763000661601 - Profile 3D™ | 2025-09-16 RING 680R28 PROFILE 3D MEXICO MDR |
| 00763000661618 - Profile 3D™ | 2025-09-16 RING 680R30 PROFILE 3D MEXICO MDR |
| 00763000661625 - Profile 3D™ | 2025-09-16 RING 680R32 PROFILE 3D MEXICO MDR |
| 00763000661632 - Profile 3D™ | 2025-09-16 RING 680R34 PROFILE 3D MEXICO MDR |
| 00763000661649 - Profile 3D™ | 2025-09-16 RING 680R36 PROFILE 3D MEXICO MDR |
| 00763000661656 - Profile 3D™ | 2025-09-16 RING 680R38 PROFILE 3D MEXICO MDR |