FDA UDI
In Commercial Distribution
🇺🇸 United States
Intelio
DI: 00810003380067
·
Model: Intelio Portable Programmer Unit
·
Impulse Dynamics (usa) Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Intelio
- Primary DI
- 00810003380067
- Version / Model
- Intelio Portable Programmer Unit
- Catalog Number
- 10-A701-3-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
- 2022-04-29
- Public Version
- 1
- Public Version Date
- 2022-05-09
- Public Version Status
- New
- Public Device Record Key
- 4f2858fc-0af3-4de4-8e68-abdcbe50f9cf
Device Description
Intelio Programmer System consists of: (1) Intelio Programming Interface (1) Getac RX10 Tablet (1) Getac RX10 Charger (1) Intelio Programming Interface - Back Lid (1) Intelio Programming Wand (1) Legacy Programming Wand (1) Guardio/Vesta Update Cable (1) ECG cable, 3 Leads Snap (1) Manual insert
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
- Yes
- 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 |
|---|---|---|---|---|
| QFV | Implantable Pulse Generator | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47467 | Cardiac contractility modulation system programmer | A portable, battery-powered device used by healthcare personnel to telemetrically receive diagnostic data from and modify the cardiac contractility signal parameters of an implanted pulse generator of a cardiac contractility modulation (CCM) system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810003380067 | GS1 |
Customer Contacts
- Phone
- 8453592389
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P180036 | 007 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 140 Degrees Fahrenheit