Duns Number:649905544
Device Description: Device Description (max 2000 characters):The NaviAid™ AB device is an accessory to an endo Device Description (max 2000 characters):The NaviAid™ AB device is an accessory to an endoscope and is intended to ensure positioning of a standardendoscope in the small intestine. It enables the advancement of a standard endoscope into the small intestinewhile utilizing the existing endoscope optics and utilities.The NaviAid™ AB Device is comprised of a balloon catheter (‘AB Disposable’) which is inserted through theinstrument channel of the endoscope, similarly to other endoscopic accessories, and a supporting single balloonair supply and control unit – NaviAid™ SPARK (‘SPARK’) for providing controlled inflation and deflation of theballoon.The NaviAid™ AB Device is indicated for use in adults and adolescent population.
Catalog Number
31-010
Brand Name
NaviAid™ AB
Version/Model Number
AB-R
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K112106,K112106
Product Code
ODC
Product Code Name
Endoscope Channel Accessory
Public Device Record Key
63694571-0ff3-42e0-a58e-fdfc36baa9d3
Public Version Date
December 10, 2020
Public Version Number
1
DI Record Publish Date
December 02, 2020
Package DI Number
17290018671648
Quantity per Package
5
Contains DI Package
07290018671634
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
5 units carton box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |