HeartSpan® FCB8563ML0/A
GUDID 00884450465943
Merit Medical Systems, Inc.
Vascular catheter introduction set, nonimplantable| Primary Device ID | 00884450465943 |
| NIH Device Record Key | dcb4b218-9beb-4536-814a-ded692def4c3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HeartSpan® |
| Version Model Number | 00884450465943 |
| Catalog Number | FCB8563ML0/A |
| 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 | false |
| 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 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 |
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| 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 |
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| 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 | 00884450465943 [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 | 2021-04-16 |
| Device Publish Date | 2021-04-08 |
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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