FDA UDI
In Commercial Distribution
🇺🇸 United States
Solo Pace Control System
DI: 00850056280037
·
Model: SOLOEPG1L
·
SOLO PACE INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Solo Pace Control System
- Primary DI
- 00850056280037
- Version / Model
- SOLOEPG1L
- Company Name
- SOLO PACE INC.
- Labeler DUNS
- 138344845
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-23
- Public Version
- 1
- Public Version Date
- 2025-01-31
- Public Version Status
- New
- Public Device Record Key
- 31b2f232-bfac-478d-8b79-a84f55a29a46
Device Description
Solo Pace Control External Pulse Generator
Device Characteristics
- Single Use
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DTE | Pulse-Generator, Pacemaker, External | Cardiovascular | 870.3600 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35224 | External pacemaker, epicardial pacing | An external pulse generator (EPG) designed to generate periodic electrical cardiac pacing impulses and transmits them to the heart via invasive (percutaneous) leads to stimulate the heart when the sino-atrial (SA) node is not functioning properly or when the heart has a conductive disorder. It is commonly used: 1) in an emergency; 2) during surgery; or 3) following open-heart surgery until the heart recovers. It is not intended for defibrillation or cardioversion. The leads (not included) are inserted into the heart through a major vein (e.g., subclavian) or attached directly to the heart wall. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850056280037 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241781 | 000 |