Primary Device ID | 00763000299842 |
NIH Device Record Key | 0ba3a2f2-4ee8-4326-b3bf-fa563b644611 |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | CB10R35R3 |
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 | true |
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 |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00763000299842 [Primary] |
DTZ | OXYGENATOR, CARDIOPULMONARY BYPASS |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-09-30 |
Device Publish Date | 2019-09-21 |
00763000894689 - SHERPA NX BALANCED™ | 2024-06-07 CATHETER SB6MP1K SB 6F 55CM MP1 |
00763000894726 - SHERPA NX BALANCED™ | 2024-06-07 CATHETER SB6MPHK SB 55CM MPH |
00763000894801 - SHERPA NX BALANCED™ | 2024-06-07 CATHETER SB6PK1W SB 6F 47CM PK1 |
00763000894917 - SHERPA NX BALANCED™ | 2024-06-07 CATHETER SB6RDCK SB 6F 55CM RDC |
00763000895754 - SHERPA NX BALANCED™ | 2024-06-07 CATHETER SB7IMAK SB 7F 55CM IMA |
00763000901905 - Launcher™ | 2024-06-07 CATHETER LA8NOTOSH LA 8F 100CM NOTO |
00763000902230 - Launcher™ | 2024-06-07 CATHETER LA8SCR35SH LA 8F 100CM SCR35 |
00763000902520 - Launcher™ | 2024-06-07 CATHETER LA83DRC LA 8F 100CM 3DRC |