FDA UDI
In Commercial Distribution
🇺🇸 United States
NaviAid™ SPARKC
DI: 07290018671504
·
Model: SPARKC
·
SMART MEDICAL SYSTEMS LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NaviAid™ SPARKC
- Primary DI
- 07290018671504
- Version / Model
- SPARKC
- Catalog Number
- 40-016
- Company Name
- SMART MEDICAL SYSTEMS LTD
- Labeler DUNS
- 649905544
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-02
- Public Version
- 1
- Public Version Date
- 2020-12-10
- Public Version Status
- New
- Public Device Record Key
- f8df187f-e162-4377-85ac-866d4e72edec
Device Description
The G-EYE® System comprises the G-EYE® Colonoscope and the NaviAid™ SPARKC (also "SPARKC") air control system which controls inflation and deflation of the G-EYE® balloon. The G-EYE® balloon is inflated using ambient air and controlled by the SPARKC via a foot pedal or a remote panel.
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| FDF | Colonoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46662 | Catheter/overtube balloon inflator, reusable | A device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290018671504 | GS1 |
Customer Contacts
- Phone
- +97297444321
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202469 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 85 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- .9 – 1.1 millibar
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- .9 – 1.1 millibar
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius