| Primary Device ID | 20613994923299 |
| NIH Device Record Key | 16653b81-bb9e-423b-8056-ed8dd43661da |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 306-02POR |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 10 |
| 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 | false |
| Single Use | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Lyophilized Heparin Assay Controls must be refrigerated (2°C to 10°C) until use. Once reconstituted, controls are stable for 2 hours at refrigerated or room temperature (2°C to 25°C). |
| Storage Environment Temperature | Between 2 Degrees Celsius and 10 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Lyophilized Heparin Assay Controls must be refrigerated (2°C to 10°C) until use. Once reconstituted, controls are stable for 2 hours at refrigerated or room temperature (2°C to 25°C). |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994923295 [Unit of Use] |
| GS1 | 20613994923299 [Primary] |
| JOX | ANALYZER, HEPARIN, AUTOMATED |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-06-18 |
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| 00763000902551 - Launcher™ | 2024-06-04 CATHETER LA83DRCSHD LA 8F 90CM 3DRC |
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| 00763000902575 - Launcher™ | 2024-06-04 CATHETER LA83DRIGHTD LA 8F 90CM 3DRGT |
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| 00763000902599 - Launcher™ | 2024-06-04 CATHETER LA8AL10D LA 8F 90CM AL10 |
| 00763000902605 - Launcher™ | 2024-06-04 CATHETER LA8AL10F LA 8F 80CM AL10 |