| Primary Device ID | 00613994558572 |
| NIH Device Record Key | ac9c0f06-30f2-4b84-92b3-d39659d8dede |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 3550-54 |
| 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 | 00613994558572 [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 |
| 00199150039371 - NA | 2025-08-22 CUSTOM PACK BB11U72R1 P/T |
| 00199150040872 - NA | 2025-08-22 CUSTOM PACK BB4K95R22 HLO PERFNPLEG |
| 00199150041145 - NA | 2025-08-22 CUSTOM PACK BB12Q87R1 HLN VAMC NASH |
| 00199150041978 - NA | 2025-08-22 CUSTOM PACK BB10F40R2 ACCESORY |
| 00199150041299 - NA | 2025-08-19 CUSTOM PACK BB8E60R12 EVL PED E |
| 20199150041118 - NA | 2025-08-18 CUSTOM PACK BB12E30R1 10PK ACC BRIDGE |
| 20199150041132 - NA | 2025-08-18 CUSTOM PACK BB5G89R2 2PK T SPRT |
| 00763000876982 - SPRINTER® LEGEND | 2025-08-18 BALLOON SPL12506X SPR LEG RX US M |