Elation™ EPB8/A
GUDID 10884450399368
Merit Medical Systems, Inc.
Gastrointestinal/biliary dilation balloon catheter| Primary Device ID | 10884450399368 |
| NIH Device Record Key | 36d8d0b1-4764-4b24-82dd-4d131bf9c4ae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Elation™ |
| Version Model Number | 00884450399361 |
| Catalog Number | EPB8/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 | 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 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884450399361 [Primary] |
| GS1 | 10884450399368 [Package] Contains: 00884450399361 Package: [20 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K151925
FDA Product Code
| FGE | Stents, drains and dilators for the biliary ducts |
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 | 2019-03-25 |
| Device Publish Date | 2019-03-15 |
On-Brand Devices [Elation™]
| 10884450399412 | 00884450399415 |
| 10884450399368 | 00884450399361 |
| 10884450399016 | 00884450399019 |
| 10884450399009 | 00884450399002 |
| 00884450398999 | 00884450398999 |
| 10884450398989 | 00884450398982 |
| 00884450398975 | 00884450398975 |
| 10884450398965 | 00884450398968 |
| 10884450398958 | 00884450398951 |
| 10884450398941 | 00884450398944 |
| 10884450398934 | 00884450398937 |
| 10884450398927 | 00884450398920 |
| 10884450398910 | 00884450398913 |
| 10884450258146 | 00884450258149 |
| 20884450258136 | 00884450258132 |
| 20884450258129 | 00884450258125 |
| 10884450258115 | 00884450258118 |
| 10884450258108 | 00884450258101 |
| 10884450258092 | 00884450258095 |
| 20884450258082 | 00884450258088 |
| 10884450258078 | 00884450258071 |
| 20884450258068 | 00884450258064 |
| 20884450258037 | 00884450258033 |
| 10884450258016 | 00884450258019 |
| 20884450258006 | 00884450258002 |
| 10884450198053 | 00884450198056 |
| 10884450198046 | 00884450198049 |
| 10884450198039 | 00884450198032 |
| 10884450198022 | 00884450198025 |
| 10884450198015 | 00884450198018 |
| 10884450198008 | 00884450198001 |
| 10884450197995 | 00884450197998 |
| 10884450197988 | 00884450197981 |
| 10884450197971 | 00884450197974 |
| 10884450197964 | 00884450197967 |
| 10884450197957 | 00884450197950 |
| 10884450197827 | 00884450197820 |
| 10884450197810 | 00884450197813 |
| 10884450197803 | 00884450197806 |
| 10884450197780 | 00884450197783 |
| 10884450197773 | 00884450197776 |
| 10884450197766 | 00884450197769 |
| 10884450399351 | 00884450399354 |
| 10884450593834 | 00884450593837 |
Trademark Results [Elation]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ELATION 97499075 not registered Live/Pending |
Piper, Gina 2022-07-12 |
 ELATION 97491791 not registered Live/Pending |
The Calida Group LLC 2022-07-06 |
 ELATION 88476802 5949769 Live/Registered |
Elation Health, Inc. 2019-06-17 |
 ELATION 88191806 not registered Live/Pending |
The Calida Group LLC 2018-11-13 |
 ELATION 87781427 not registered Dead/Abandoned |
Mohawk Carpet, LLC 2018-02-02 |
 ELATION 87294275 not registered Live/Pending |
Worthy Brewing, LLC 2017-01-09 |
 ELATION 86893037 5040395 Live/Registered |
Satulovsky, Carlos 2016-02-01 |
 ELATION 86573012 not registered Dead/Abandoned |
Integral Associates, LLC 2015-03-23 |
 ELATION 86572097 not registered Dead/Abandoned |
Integral Associates, LLC 2015-03-21 |
 ELATION 86002138 5469873 Live/Registered |
A. Hardy U.S.A. Ltd. 2013-07-03 |
 ELATION 85847126 4442725 Live/Registered |
Elation, Inc. 2013-02-12 |
 ELATION 85534658 4846284 Live/Registered |
Merit Medical Systems, Inc. 2012-02-06 |
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