FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SQ-RX® PULSE GENERATOR
DI: 00802526521300
·
Model: 1010
·
CAMERON HEALTH, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SQ-RX® PULSE GENERATOR
- Primary DI
- 00802526521300
- Version / Model
- 1010
- Company Name
- CAMERON HEALTH, INC.
- Labeler DUNS
- 017134557
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 5
- Public Version Date
- 2021-03-19
- Public Version Status
- Update
- Public Device Record Key
- f5c4e362-9ab5-4b78-88d6-45be960ceba0
- Distribution End Date
- 2020-06-17
Device Description
SQ-RX Pulse Generator
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
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| LWS | Implantable cardioverter defibrillator (non-CRT) | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35852 | Single-chamber implantable defibrillator | An implantable pulse generator (IPG) with a cardiac rhythm recognition system, to analyse an electrocardiogram (ECG), intended to deliver an electrical impulse(s) to defibrillate the heart (restore normal rhythm) or slow a rapid heart rate, and typically to pace a slow heart rate. It is implanted in a pouch beneath the skin of the patient's chest or abdomen and has connected a lead(s) that are positioned inside or on one heart chamber (typically right ventricle) to monitor the ECG and to automatically deliver the electrical impulse. It has internal batteries that provide the energy for the discharges; it is commonly known as an automatic implantable cardioverter-defibrillator (AICD). | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00802526521300 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P110042 | 000 |
| P110042 | 002 |
| P110042 | 003 |
| P110042 | 004 |
| P110042 | 007 |
| P110042 | 011 |
| P110042 | 012 |
| P110042 | 014 |
| P110042 | 016 |
| P110042 | 021 |