| Primary Device ID | 20884450708860 |
| NIH Device Record Key | 0573708f-b61f-49a3-ba35-43ee1937e883 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Prelude ACT™ |
| Version Model Number | F |
| Catalog Number | PSI-7F-11ACT |
| Company DUNS | 184763290 |
| Company Name | Merit Medical Systems, Inc. |
| Device Count | 5 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884450708866 [Unit of Use] |
| GS1 | 10884450708863 [Primary] |
| GS1 | 20884450708860 [Package] Contains: 10884450708863 Package: [4 Units] In Commercial Distribution |
| DRE | DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-04 |
| Device Publish Date | 2024-08-27 |
| 20884450331938 | 10884450331931 |
| 20884450331914 | 10884450331917 |
| 20884450331815 | 10884450331818 |
| 20884450331730 | 10884450331733 |
| 20884450331624 | 10884450331627 |
| 20884450331525 | 10884450331528 |
| 20884450331501 | 10884450331504 |
| 20884450331839 | 10884450331832 |
| 20884450602915 | 10884450602918 |
| 20884450615205 | 10884450615208 |
| 20884450614802 | 10884450614805 |
| 20884450614727 | 10884450614720 |
| 20884450614680 | 10884450614683 |
| 20884450614482 | 10884450614485 |
| 20884450614178 | 10884450614171 |
| 20884450614437 | 10884450614430 |
| 20884450615182 | 10884450615185 |
| 20884450709119 | F |
| 20884450708846 | F |
| 20884450707832 | F |
| 20884450707153 | F |
| 20884450706156 | F |
| 20884450709133 | F |
| 20884450708860 | F |
| 20884450707863 | F |
| 20884450707177 | F |