PreludeSYNC EVO™ SRB24LBAC
GUDID 20884450400443
Merit Medical Systems, Inc.
Vascular compressor, external| Primary Device ID | 20884450400443 |
| NIH Device Record Key | 84dfc1f8-83c1-4f5b-a80f-a586ed11dc10 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PreludeSYNC EVO™ |
| Version Model Number | 10884450400446 |
| Catalog Number | SRB24LBAC |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | false |
Device Dimensions
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884450400449 [Unit of Use] |
| GS1 | 10884450400446 [Primary] |
| GS1 | 20884450400443 [Package] Contains: 10884450400446 Package: [4 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K180723
FDA Product Code
| DXC | CLAMP, VASCULAR |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-06-24 |
| Device Publish Date | 2019-06-14 |
On-Brand Devices [PreludeSYNC EVO™]
| 20884450400443 | 10884450400446 |
| 20884450462946 | 10884450462949 |
| 20884450567870 | 10884450567873 |
| 20884450567818 | 10884450567811 |
| 20884450462953 | 10884450462956 |
| 20884450400467 | 10884450400460 |
Trademark Results [PreludeSYNC EVO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PRELUDESYNC EVO 88438690 not registered Live/Pending |
Merit Medical Systems, Inc. 2019-05-20 |
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