NaviAid™ ABC

FDA UDI

Class II (US FDA UDI)

by Smart Medical Systems Ltd

Identity

Trade Name: NaviAid™ ABC FDA UDI
Generic Name: Catheter/overtube balloon inflator, single-use FDA UDI
Device Name: The NaviAid™ ABC device is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope during endoscopy of the small and large intestine (standard endoscope-i.e., an endoscope that has an instrument channel that is at least 3.7mm diameter and is used for standard endoscopic visualization). The NaviAid™ ABC Device is comprised of a balloon catheter (‘ABC 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™ ABC Device is indicated for use in adults and adolescent population. FDA UDI
Model / Reference: ABC FDA UDI
Description: The NaviAid™ ABC device is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope during endoscopy of the small and large intestine (standard endoscope-i.e., an endoscope that has an instrument channel that is at least 3.7mm diameter and is used for standard endoscopic visualization). The NaviAid™ ABC Device is comprised of a balloon catheter (‘ABC 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™ ABC Device is indicated for use in adults and adolescent population. FDA UDI

Identifiers

Catalog Number: 23-010 FDA UDI
Primary DI / UDI-DI: 07290018671658 FDA UDI
510(k) Number: K111760 FDA UDI
FDA Product Code: ODC FDA UDI
GMDN Term: Catheter/overtube balloon inflator, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Catheter/overtube balloon inflator, single-use

NaviAid™ ABC by Smart Medical Systems Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Catheter/overtube balloon inflator, single-use.

basixCOMPAK™ — Merit Medical Systems, Inc. · Class II
Monarch® — Merit Medical Systems, Inc. · Class II
Merit Medical® — Merit Medical Systems, Inc. · Class II
Merit Medical® — Merit Medical Systems, Inc. · Class II
Merit Medical® — Merit Medical Systems, Inc. · Class II
Merit Medical® — Merit Medical Systems, Inc. · Class II
Merit Medical® — Merit Medical Systems, Inc. · Class II
Merit Medical® — Merit Medical Systems, Inc. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Smart Medical Systems Ltd

Sources (1)

FDA UDI 7330c094-d6c8-4a16-b7c3-c618bd06a592 36 fields · synced May 30, 2026