Primary Device ID | 20763000380827 |
NIH Device Record Key | eb0d5d64-4c18-44e1-bf01-99ca47e9d6a2 |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | TL2U38R2 |
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 50 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00763000380816 [Primary] |
GS1 | 20763000380827 [Package] Contains: 00763000380816 Package: PK [5 Units] In Commercial Distribution |
DWF | Catheter, cannula and tubing, vascular, 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 | 2020-04-27 |
Device Publish Date | 2020-04-18 |
00763000990534 - NA | 2024-12-31 CUSTOM PACK SSBB12H98R5 ADULT PACK |
00763000989903 - NA | 2024-12-30 CUSTOM PACK BB12H87R2 3/8 E PACK |
00763000989729 - NA | 2024-12-27 CUSTOM PACK BB8S01R5 CITRS AVL |
20763000989754 - NA | 2024-12-27 CUSTOM PACK BB12G31R2 4PK ENOE CPL |
20763000989846 - NA | 2024-12-27 CUSTOM PACK BB11L70R1 4PK CP 2013 |
00763000708917 - DiamondTemp™ FASTR RF Generator | 2024-12-23 GENERATOR CEDTG200 FASTR RF US |
00763000709051 - DiamondTemp™ Irrigation Pump | 2024-12-23 IRRIGATION PUMP CEDTP100 US |
00763000989156 - NA | 2024-12-23 CUSTOM PACK BB11C49R9 1/4 PACK |