HeartSpan® HST-085-10/B
GUDID 10884450489724
Merit Medical Systems, Inc.
Cardiac transseptal access set| Primary Device ID | 10884450489724 |
| NIH Device Record Key | d3b2720f-1b62-4274-964e-2eb7cbd4f323 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HeartSpan® |
| Version Model Number | 00884450489727 |
| Catalog Number | HST-085-10/B |
| Company DUNS | 184763290 |
| Company Name | Merit Medical Systems, Inc. |
| Device Count | 1 |
| 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 | true |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884450489727 [Primary] |
| GS1 | 10884450489724 [Package] Contains: 00884450489727 Package: [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K170668
FDA Product Code
| DYB | INTRODUCER, CATHETER |
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 | 2020-08-18 |
| Device Publish Date | 2020-08-10 |
On-Brand Devices [HeartSpan®]
Trademark Results [HeartSpan]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEARTSPAN 87043746 5064437 Live/Registered |
Merit Medical Systems, Inc. 2016-05-19 |
 HEARTSPAN 77169337 3680277 Dead/Cancelled |
Thomas Medical Products, Inc. 2007-04-30 |
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