Primary Device ID | 05415067049520 |
NIH Device Record Key | af6e6211-8f12-41da-8150-406ab89d792b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Gallant™ |
Version Model Number | CDHFA500T |
Catalog Number | CDHFA500T |
Company DUNS | 790268031 |
Company Name | ST. JUDE MEDICAL, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Conditional |
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 | true |
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(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources. |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources. |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources. |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources. |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources. |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources. |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources. |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources. |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources. |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources. |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources. |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05415067049520 [Primary] |
NIK | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-05-03 |
Device Publish Date | 2024-04-25 |
05415067032010 | Cardiac Resynchronisation Therapy Defibrillator |
05415067032003 | Implantable Cardioverter Defibrillator |
05415067031990 | Implantable Cardioverter Defibrillator |
05415067049520 | HF Cardiac Resynchronization Therapy Defibrillator |
05415067049476 | DR Implantable Cardioverter Defibrillator |
05415067049421 | VR Implantable Cardioverter Defibrillator |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
GALLANT 98692425 not registered Live/Pending |
Tenkoz, Inc. 2024-08-10 |
GALLANT 98029922 not registered Live/Pending |
Lewis, Kenneth 2023-06-06 |
GALLANT 97390558 not registered Live/Pending |
LENS BUY INC 2022-05-01 |
GALLANT 97301954 not registered Live/Pending |
JPJ & Company 2022-03-08 |
GALLANT 90815044 not registered Live/Pending |
GALLANT ( HONGKONG ) ENTERPRISE CO., LIMITED 2021-07-07 |
GALLANT 90189412 not registered Live/Pending |
Tenkoz, Inc. 2020-09-17 |
GALLANT 88644453 not registered Live/Pending |
Tacony Corporation 2019-10-07 |
GALLANT 88586572 not registered Live/Pending |
Triangle Tube Phase III Co. 2019-08-21 |
GALLANT 88402760 not registered Live/Pending |
Pet Labs Inc. 2019-04-25 |
GALLANT 88235868 5805404 Live/Registered |
TIRELINK CO., LTD 2018-12-19 |
GALLANT 87945940 not registered Dead/Abandoned |
Kalea Wear Inc 2018-06-02 |
GALLANT 87520053 not registered Live/Pending |
Medinol, Ltd. 2017-07-07 |