FDA UDI
In Commercial Distribution
🇺🇸 United States
OPTIMIZER™
DI: 00810003380050
·
Model: CCM X10
·
Impulse Dynamics (usa) Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OPTIMIZER™
- Primary DI
- 00810003380050
- Version / Model
- CCM X10
- Catalog Number
- 10-B411-3-XX
- Company Name
- Impulse Dynamics (usa) Inc.
- Labeler DUNS
- 878519342
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-28
- Public Version
- 1
- Public Version Date
- 2021-01-05
- Public Version Status
- New
- Public Device Record Key
- c274906e-b972-472a-b8d6-8424446efb86
Device Description
OPTIMIZER Smart Implantable Pulse Generator for the Treatment of Heart Failure System consists of: (1) OPTIMIZER Smart Implantable Pulse Generator (IPG) (1) Allen #2 torque wrench (1) Port Plug
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QFV | Implantable Pulse Generator | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47468 | Cardiac contractility modulation system pulse generator | A hermetically-sealed, battery-powered device implanted beneath the skin to produce electrical signals delivered to the heart via implantable cardiac pacing leads during the ventricular absolute refractory period (ARP) to enhance the strength of the heart [cardiac contractility modulation (CCM)], typically as treatment for heart failure. The device is programmed by and transmits cardiac diagnostic data to an external programmer telemetrically. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810003380050 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P180036 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 104 Degrees Fahrenheit