Primary Device ID | 00643169713901 |
NIH Device Record Key | afe19204-09b9-4eb6-9b00-1184f7a89a28 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Ensemble™ ll |
Version Model Number | ENS1022 |
Company DUNS | 006261481 |
Company Name | MEDTRONIC, 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 | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com |
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 |
Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Sunlight |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00643169713901 [Primary] |
NPV | Pulmonary valve prosthesis percutaneously delivered |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2019-10-07 |
Device Publish Date | 2016-10-31 |
00643169713901 | DELIV SYS ENS1022 ENSEMBLE II US |
00643169713895 | DELIV SYS ENS1020 ENSEMBLE II US |
00643169713888 | DELIV SYS ENS1018 ENSEMBLE II US |