Current Accel™ CD1215-36Q
GUDID 05414734503044
Tiered-therapy cardioverter/defibrillator VVEV VVIR
ST. JUDE MEDICAL, INC.
Single-chamber implantable defibrillator| Primary Device ID | 05414734503044 |
| NIH Device Record Key | ea26de88-4764-4dd2-b3d4-d839ee94a586 |
| Commercial Distribution Discontinuation | 2018-02-13 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Current Accel™ |
| Version Model Number | VR |
| Catalog Number | CD1215-36Q |
| 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 |
Device Dimensions
| Total Volume | 41 Milliliter |
| Total Volume | 41 Milliliter |
| Total Volume | 41 Milliliter |
| Total Volume | 41 Milliliter |
| Total Volume | 41 Milliliter |
| Total Volume | 41 Milliliter |
| Total Volume | 41 Milliliter |
| Total Volume | 41 Milliliter |
| Total Volume | 41 Milliliter |
| Total Volume | 41 Milliliter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store the device away from magnets and sources of electromagnetic interference. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device away from magnets and sources of electromagnetic interference. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device away from magnets and sources of electromagnetic interference. |
| Special Storage Condition, Specify | Between 0 and 0 *Store the device away from magnets and sources of electromagnetic interference. |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 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 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 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 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 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 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 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 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 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 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 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 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 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 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 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 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| 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 | 05414734503044 [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 | 2020-05-04 |
| Device Publish Date | 2017-01-24 |
On-Brand Devices [Current Accel™]
| 05414734503044 | Tiered-therapy cardioverter/defibrillator VVEV VVIR |
| 05414734502634 | Tiered-therapy cardioverter/defibrillator VVEV VVIR |
Trademark Results [Current Accel]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CURRENT ACCEL 77412923 3768133 Dead/Cancelled |
Pacesetter, Inc. 2008-03-04 |
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