Fortify Assura™ CD2257-40Q
GUDID 05414734505550
Tiered-therapy cardioverter/defibrillator VVED DDDR
ST. JUDE MEDICAL, INC.
Dual-chamber implantable defibrillator| Primary Device ID | 05414734505550 |
| NIH Device Record Key | 83e23e71-4bd0-4533-843e-a9719a2b4058 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fortify Assura™ |
| Version Model Number | DR |
| Catalog Number | CD2257-40Q |
| Company DUNS | 790268031 |
| Company Name | ST. JUDE MEDICAL, 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 | true |
| 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 |
Customer Support Contacts
| 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 | |
| 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 |
Device Dimensions
| Total Volume | 35 Milliliter |
| Total Volume | 35 Milliliter |
| Total Volume | 35 Milliliter |
| Total Volume | 35 Milliliter |
| Total Volume | 35 Milliliter |
| Total Volume | 35 Milliliter |
| Total Volume | 35 Milliliter |
| Total Volume | 35 Milliliter |
| Total Volume | 35 Milliliter |
| Total Volume | 35 Milliliter |
| Total Volume | 35 Milliliter |
| Total Volume | 35 Milliliter |
| Total Volume | 35 Milliliter |
| Total Volume | 35 Milliliter |
| Total Volume | 35 Milliliter |
| Total Volume | 35 Milliliter |
| Total Volume | 35 Milliliter |
| Total Volume | 35 Milliliter |
| Total Volume | 35 Milliliter |
| Total Volume | 35 Milliliter |
| Total Volume | 35 Milliliter |
| Total Volume | 35 Milliliter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device away from magnets and sources of electromagnetic interference. |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device away from magnets and sources of electromagnetic interference. |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device away from magnets and sources of electromagnetic interference. |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device away from magnets and sources of electromagnetic interference. |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device away from magnets and sources of electromagnetic interference. |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device away from magnets and sources of electromagnetic interference. |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device away from magnets and sources of electromagnetic interference. |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device away from magnets and sources of electromagnetic interference. |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device away from magnets and sources of electromagnetic interference. |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device away from magnets and sources of electromagnetic interference. |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device away from magnets and sources of electromagnetic interference. |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device away from magnets and sources of electromagnetic interference. |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device away from magnets and sources of electromagnetic interference. |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device away from magnets and sources of electromagnetic interference. |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device away from magnets and sources of electromagnetic interference. |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device away from magnets and sources of electromagnetic interference. |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device away from magnets and sources of electromagnetic interference. |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device away from magnets and sources of electromagnetic interference. |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device away from magnets and sources of electromagnetic interference. |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device away from magnets and sources of electromagnetic interference. |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device away from magnets and sources of electromagnetic interference. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05414734505550 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P910023
FDA Product Code
| NVZ | Pulse generator, permanent, implantable |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2020-01-27 |
| Device Publish Date | 2017-02-03 |
On-Brand Devices [Fortify Assura™]
| 05414734508094 | Tiered-therapy cardioverter/defibrillator VVED DDDR |
| 05414734508087 | Tiered-therapy cardioverter/defibrillator VVED DDDR |
| 05414734508070 | Tiered-therapy cardioverter/defibrillator VVED DDDR |
| 05414734508063 | Tiered-therapy cardioverter/defibrillator VVED DDDR |
| 05414734507974 | Tiered-therapy cardioverter/defibrillator VVEV VVIR |
| 05414734507967 | Tiered-therapy cardioverter/defibrillator VVEV VVIR |
| 05414734507950 | Tiered-therapy cardioverter/defibrillator VVEV VVIR |
| 05414734507943 | Tiered-therapy cardioverter/defibrillator VVEV VVIR |
| 05414734505550 | Tiered-therapy cardioverter/defibrillator VVED DDDR |
| 05414734505543 | Tiered-therapy cardioverter/defibrillator VVED DDDR |
| 05414734505475 | Tiered-therapy cardioverter/defibrillator VVEV VVIR |
| 05414734505468 | Tiered-therapy cardioverter/defibrillator VVEV VVIR |
Trademark Results [Fortify Assura]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FORTIFY ASSURA 85392023 4199898 Live/Registered |
Pacesetter, Inc. 2011-08-08 |
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