FDA UDI
In Commercial Distribution
🇺🇸 United States
NaviAid™ AB
DI: 07290018671634
·
Model: AB-R
·
SMART MEDICAL SYSTEMS LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NaviAid™ AB
- Primary DI
- 07290018671634
- Version / Model
- AB-R
- Catalog Number
- 31-010
- 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
- 63694571-0ff3-42e0-a58e-fdfc36baa9d3
Device Description
Device Description (max 2000 characters): The NaviAid™ AB device is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope in the small intestine. It enables the advancement of a standard endoscope into the small intestine while utilizing the existing endoscope optics and utilities. The NaviAid™ AB Device is comprised of a balloon catheter (‘AB Disposable’) which is inserted through the instrument channel of the endoscope, similarly to other endoscopic accessories, and a supporting single balloon air supply and control unit – NaviAid™ SPARK (‘SPARK’) for providing controlled inflation and deflation of the balloon.The NaviAid™ AB Device is indicated for use in adults and adolescent population.
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ODC | Endoscope Channel Accessory | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17541 | Catheter/overtube balloon inflator, single-use | 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 single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290018671634 | GS1 | ||||
| Package | 17290018671648 | GS1 | 5 units carton box | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- +97297444321
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K112106 | 000 |