HeartSpan® FCB8581MR0
GUDID 00884450404850
Merit Medical
Cardiac transseptal access set| Primary Device ID | 00884450404850 |
| NIH Device Record Key | 01f18043-fd69-4b17-9eba-0b8d8ee4b9f7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HeartSpan® |
| Version Model Number | 00884450404850 |
| Catalog Number | FCB8581MR0 |
| Company DUNS | 065673912 |
| Company Name | Merit Medical |
| 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 | 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 |
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Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884450404850 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K132720
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 | 2019-04-12 |
| Device Publish Date | 2019-04-04 |
On-Brand Devices [HeartSpan®]
| 00884450404867 | 00884450404867 |
| 00884450312810 | 00884450312810 |
| 00884450312803 | 00884450312803 |
| 00884450312797 | 00884450312797 |
| 00884450286456 | 00884450286456 |
| 00884450286449 | 00884450286449 |
| 00884450286210 | 00884450286210 |
| 00884450266250 | 00884450266250 |
| 00884450266243 | 00884450266243 |
| 00884450263204 | 00884450263204 |
| 00884450263198 | 00884450263198 |
| 00884450263181 | 00884450263181 |
| 00884450263174 | 00884450263174 |
| 00884450263167 | 00884450263167 |
| 00884450263150 | 00884450263150 |
| 00884450261071 | 00884450261071 |
| 00884450261064 | 00884450261064 |
| 00884450261057 | 00884450261057 |
| 00884450261040 | 00884450261040 |
| 00884450261033 | 00884450261033 |
| 00884450261026 | 00884450261026 |
| 00884450261019 | 00884450261019 |
| 00884450261002 | 00884450261002 |
| 00884450260999 | 00884450260999 |
| 00884450260982 | 00884450260982 |
| 00884450260975 | 00884450260975 |
| 00884450260968 | 00884450260968 |
| 00884450260951 | 00884450260951 |
| 00884450260944 | 00884450260944 |
| 00884450258187 | 00884450258187 |
| 00884450198520 | 00884450198520 |
| 00884450198490 | 00884450198490 |
| 00884450198483 | 00884450198483 |
| 00884450169759 | 00884450169759 |
| 00884450169742 | 00884450169742 |
| 00884450169735 | 00884450169735 |
| 00884450169728 | 00884450169728 |
| 00884450169711 | 00884450169711 |
| 00884450169704 | 00884450169704 |
| 10884450169206 | 00884450169209 |
| 10884450169190 | 00884450169193 |
| 10884450169183 | 00884450169186 |
| 10884450169176 | 00884450169179 |
| 10884450169169 | 00884450169162 |
| 10884450169152 | 00884450169155 |
| 10884450169145 | 00884450169148 |
| 10884450169138 | 00884450169131 |
| 00884450169124 | 00884450169124 |
| 10884450169114 | 00884450169117 |
| 10884450169077 | 00884450169070 |
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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