Primary Device ID | 00613994753304 |
NIH Device Record Key | 65c38291-9862-4f17-90db-f2fcf1c6eaee |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Syncra™ CRT-P |
Version Model Number | C2TR01 |
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 | 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 |
Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Handling Environment Temperature | Between -18 Degrees Celsius and 55 Degrees Celsius |
Handling Environment Temperature | Between 0 Degrees Fahrenheit and 131 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00613994753304 [Primary] |
NKE | Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-06-28 |
Device Publish Date | 2014-09-23 |
00763000960308 - NA | 2024-07-09 CUSTOM PACK BB12C30R7 NPR IMC |
00763000960407 - NA | 2024-07-09 CUSTOM PACK BB12G16R3 UCHICAGO CPB |
00763000228699 - NA | 2024-07-08 KIT 20MRK ARCTIC FRNT MANETRACT GLB TIJ |
00763000957193 - NA | 2024-07-08 CUSTOM PACK BB7M46R25 SCV ADLT |
20763000960272 - NA | 2024-07-08 CUSTOM PACK 10R91R5 10PK LRTXBYPS |
20763000960296 - NA | 2024-07-08 CUSTOM PACK SSBB12D06R4 4PK RESOXY BYPA |
00763000879273 - Verify™ | 2024-07-05 ENS 353101 VERIFY ISTM US EMANUAL |
00763000879280 - Verify™ | 2024-07-05 ENS 353101 VERIFY ISTM US REFURB EMAN |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SYNCRA 88391995 not registered Live/Pending |
Sunrise Medical (US) LLC 2019-04-18 |
SYNCRA 88057549 not registered Dead/Abandoned |
Carrier Corporation 2018-07-30 |
SYNCRA 86214746 4740430 Live/Registered |
Ecolab USA Inc. 2014-03-07 |
SYNCRA 79064733 3778219 Dead/Cancelled |
Danisco US Inc. 2008-12-30 |
SYNCRA 77869384 4354262 Live/Registered |
Medtronic, Inc. 2009-11-10 |
SYNCRA 76322217 2642520 Dead/Cancelled |
Syncra Systems, Inc. 2001-10-05 |
SYNCRA 76321847 2665986 Dead/Cancelled |
Syncra Systems, Inc. 2001-10-05 |
SYNCRA 75444211 not registered Dead/Abandoned |
CollabTech, Inc. 1998-03-04 |