Current Accel® CD2215-36
GUDID H758CD2215360
Tiered-therapy cardioverter/defibrillator VVED DDDR
ST. JUDE MEDICAL, INC.
Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator Dual-chamber implantable defibrillator| Primary Device ID | H758CD2215360 |
| NIH Device Record Key | d3aaf0f3-7f4b-46f5-b183-24890942ad76 |
| Commercial Distribution Discontinuation | 2018-02-13 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Current Accel® |
| Version Model Number | DR |
| Catalog Number | CD2215-36 |
| 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 | 42 Milliliter |
| Total Volume | 42 Milliliter |
| Total Volume | 42 Milliliter |
| Total Volume | 42 Milliliter |
| Total Volume | 42 Milliliter |
| Total Volume | 42 Milliliter |
| Total Volume | 42 Milliliter |
| Total Volume | 42 Milliliter |
| Total Volume | 42 Milliliter |
| Total Volume | 42 Milliliter |
Operating and Storage Conditions
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05414734502641 [Primary] |
| HIBCC | H758CD2215360 [Secondary] |
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 | 2014-10-24 |
On-Brand Devices [Current Accel®]
| 05414734503075 | Tiered-therapy cardioverter/defibrillator VVED DDDR |
| H758CD2215360 | Tiered-therapy cardioverter/defibrillator VVED DDDR |
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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