NSS IB-STIM

Basic Information

• Brand Name: NSS IB-STIM
• Primary DI: B960NSS203
• Version / Model: IB-STIM
• Catalog Number: 01-1020
• Company Name: Neuraxis, Inc.
• Labeler DUNS: 063076701
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-09
• Public Version: 9
• Public Version Date: 2025-10-28
• Public Version Status: Update
• Public Device Record Key: 7a772919-6c75-4ab6-86ea-7097ba69c0a5

Device Description

The IB-STIM (DEN180057) is a percutaneous electrical nerve field stimulator (PENFS) system, which is used in a target population of patients 8 years of age or older with functional abdominal pain associated with irritable bowel syndrome (IBS) and/or functional dyspepsia. The IB-STIM is a battery-operated micro-stimulation appliance designed as a disposable product for a single use. The IB-STIM is placed behind the patient’s ear and connected to stimulation needles on the auricle. The IB-STIM offers regular therapy over several days and is intended to be used for 120 hours per week up to 4 consecutive weeks. The appliance transmits low-frequency electric pulses to exposed nerve endings.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QHH	Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)	Gastroenterology, Urology	876.5340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63321	Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator	A body-worn, electronic device intended to provide percutaneous electrical nerve field stimulation (PENFS) applied close to cranial/peripheral nerves around the external ear to achieve remote symptom relief mediated by central nervous system (CNS) pathways and structures [e.g., amygdala, spinal cord neurons]; depending on the treatment protocol and device settings it may be used for opioid withdrawal symptoms (e.g., bone/joint aches, tremor, anxiety), or irritable bowel syndrome [IBS]-associated functional abdominal pain (FAP). It consists of an electrical pulse generator with minimally-invasive electrodes, and accessories (e.g., adhesives, transilluminator). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B960NSS2031	HIBCC	Box	10	In Commercial Distribution
Primary	B960NSS203	HIBCC
Package	B960NSS2032	HIBCC	BOX	20	In Commercial Distribution
Previous	B327NSS203	HIBCC
Package	B960NSS2033	HIBCC	Box	5	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]