Primary Device ID | 00763000989156 |
NIH Device Record Key | 482fed70-5587-4cf5-b490-b124d1a1f9ea |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | BB11C49R9 |
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 |
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 | 00763000989156 [Primary] |
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 | 2024-12-23 |
Device Publish Date | 2024-12-15 |
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 | 2024-12-23CUSTOM PACK BB11C49R9 1/4 PACK |
00763000989156 - NA | 2024-12-23 CUSTOM PACK BB11C49R9 1/4 PACK |
00763000989163 - NA | 2024-12-23 CUSTOM PACK BB12M25R1 TAPER BOOT |
20763000989242 - NA | 2024-12-23 CUSTOM PACK BB12M13R1 5PK EP BRIDGE |
00763000893910 - SHERPA NX BALANCED™ | 2024-12-20 CATHETER SB6FL40SH SB 6F 100CM FL40 |
00763000893941 - SHERPA NX BALANCED™ | 2024-12-20 CATHETER SB6FR40SH SB 6F 100CM FR40 |
00763000988258 - NA | 2024-12-20 CUSTOM PACK BB10Q85R1 FILTER |