MOSAIC ULTRA®
GUDID 00613994760647
VALVE 305U221 MOS AOR ULT CINCHII US
MEDTRONIC, INC.
Aortic heart valve bioprosthesis| Primary Device ID | 00613994760647 |
| NIH Device Record Key | 182bf3fb-dbcf-4f24-b2c8-da59ad6b8bb0 |
| Commercial Distribution Discontinuation | 2017-11-30 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | MOSAIC ULTRA® |
| Version Model Number | 305U221 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994760647 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P990064
FDA Product Code
| LWR | heart-valve, non-allograft tissue |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2014-09-23 |
On-Brand Devices [MOSAIC ULTRA®]
| 00613994760661 | VALVE 305U219 MOS AOR ULT CINCHII US |
| 00613994760647 | VALVE 305U221 MOS AOR ULT CINCHII US |
| 00613994760630 | VALVE 305U223 MOS AOR ULT CNCHII NNA US |
| 00613994760623 | VALVE 305U223 MOS AOR ULT CINCHII US |
| 00613994760616 | VALVE 305U225 MOS AOR ULT CNCHII NNA US |
| 00613994760609 | VALVE 305U225 MOS AOR ULT CINCHII US |
| 00613994760593 | VALVE 305U227 MOS AOR ULT CINCHII US |
| 00613994760586 | VALVE 305U229 MOS AOR ULT CINCHII US |
| 00613994479365 | VALVE 305U219 MOS AOR ULT CINCHII US |
| 00613994479259 | VALVE 305U221 MOS AOR ULT CINCHII US |
| 00613994479242 | VALVE 305U223 MOS AOR ULT CINCHII US |
| 00613994479235 | VALVE 305U225 MOS AOR ULT CINCHII US |
| 00613994479228 | VALVE 305U227 MOS AOR ULT CINCHII US |
| 00613994479211 | VALVE 305U229 MOS AOR ULT CINCHII US |
| 00643169001879 | VLV 305U219 MOSAIC AOR ULT CII US TEMP I |
| 00643169001862 | VLV 305U219 MOSAIC AOR ULT CII NNA US TE |
| 00643169001848 | VLV 305U221 MOSAIC AOR ULT CII US TEMP I |
| 00643169001831 | VLV 305U221 MOSAIC AOR ULT CII NNA US TE |
| 00643169001664 | VLV 305U223 MOSAIC AOR ULT CII US TEMP I |
| 00643169001558 | VLV 305U223 MOSAIC AOR ULT CII NNA US TE |
| 00643169001534 | VLV 305U225 MOSAIC AOR ULT CII US TEMP I |
| 00643169001527 | VLV 305U225 MOSAIC AOR ULT CII NNA US TE |
| 00643169001503 | VLV 305U227 MOSAIC AOR ULT CII US TEMP I |
| 00643169001480 | VLV 305U229 MOSAIC AOR ULT CII US TEMP I |
| 00643169595026 | VLV 305U225 MOSAIC AORULT CII NNAUS PEEK |
| 00643169595019 | VLV 305U223 MOSAIC AORULT CII NNAUS PEEK |
| 00643169595002 | VLV 305U221 MOSAIC AORULT CII NNAUS PEEK |
| 00643169594999 | VLV 305U219 MOSAIC AORULT CII NNAUS PEEK |
| 00643169594982 | VLV 305U229 MOSAIC AORULT CII US PEEK |
| 00643169594975 | VLV 305U227 MOSAIC AORULT CII US PEEK |
| 00643169594968 | VLV 305U225 MOSAIC AORULT CII US PEEK |
| 00643169594951 | VLV 305U223 MOSAIC AORULT CII US PEEK |
| 00643169594944 | VLV 305U221 MOSAIC AORULT CII US PEEK |
| 00643169594937 | VLV 305U219 MOSAIC AORULT CII US PEEK |
| 00885074253305 | VALVE 305U23 MOSAIC AOR ULTRA US |
| 00885074253275 | VALVE 305U29 MOSAIC AOR ULTRA US |
| 00885074253268 | VALVE 305U27 MOSAIC AOR ULTRA US |
| 00885074253251 | VALVE 305U25 MOSAIC AOR ULTRA US |
| 00885074253244 | VALVE 305U23 MOSAIC AOR ULTRA US |
| 00885074253220 | VALVE 305U21 MOSAIC AOR ULTRA US |
| 00885074253213 | VALVE 305U19 MOSAIC AOR ULTRA US |
Trademark Results [MOSAIC ULTRA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MOSAIC ULTRA 78470205 3294682 Live/Registered |
Medtronic, Inc. 2004-08-19 |
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