Sparrow Ascent Kit (B2B)

GUDID 00860005396986

The Sparrow Ascent is a transcutaneous auricular neurostimulation (tAN) system intended to provide non-invasive, transcutaneous stimulation of the nerves on and/or around the auricle (ear). The device is indicated as an aid in the reduction of opioid withdrawal symptoms in adult patients. The Sparrow Ascent is a battery operated, prescription device that delivers mild electrical stimulation to the nerves on and/or around the auricle (ear), which carry information to the central nervous system. The Sparrow Ascent is to be used in clinical environments (e.g., doctor’s office, clinics, rehab centers, and hospitals) and/or at home. Users of the subject device include adults experiencing opioid withdrawal symptoms. Stimulation parameters (i.e., the strength of stimulation) are set by the user’s clinician, and users can only adjust stimulation intensity at home. The system consists of three main components 1) a disposable Earpiece, 2) a Cable, and 3) the External Pulse Generator (EPG).

Spark Biomedical Inc.

Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator

• Primary Device ID: 00860005396986
• NIH Device Record Key: 1c79cd7c-5f81-4155-9ca6-baad0b1859dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sparrow Ascent Kit (B2B)
• Version Model Number: 11-320-K
• Company DUNS: 074715155
• Company Name: Spark Biomedical Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860005396986 [Primary]

FDA Product Code

• PZR: Percutaneous Nerve Stimulator For Opioid Withdrawal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-15
• Device Publish Date: 2023-09-07

Devices Manufactured by Spark Biomedical Inc.

• 00850052017019 - Sparrow Ascent Earpiece, Right: 2023-09-15 The Earpiece is a disposable component of the Sparrow Ascent and is designed to stay adhered to the skin of the left or right ea
• 00850052017033 - Sparrow Ascent Replacement Kit: 2023-09-15 Separate item for replacement. The Sparrow Ascent Patient Controller is a transcutaneous auricular neurostimulation (tAN) system
• 00850052017040 - Sparrow Ascent Cable: 2023-09-15 The Sparrow Ascent Cable is 37 inches long and connects the Patient Controller to the Earpiece. The Cable length is designed to
• 00850052017071 - Sparrow Ascent 28 Piece Kit (B2B): 2023-09-15 A starter pack with all the components for acute withdrawal management using Transcutaneous Auricular Neurostimulation (tAN®).
• 00850052017088 - Sparrow Ascent 28 Piece Kit (B2C): 2023-09-15 A starter pack with all the components for acute withdrawal management using Transcutaneous Auricular Neurostimulation (tAN®).
• 00860005396948 - Sparrow Ascent Kit (B2C): 2023-09-15 The Sparrow Ascent is a transcutaneous auricular neurostimulation (tAN) system intended to provide non-invasive, transcutaneous
• 00860005396955 - Sparrow Ascent Patient Controller: 2023-09-15 The Sparrow Ascent Patient Controller is a transcutaneous auricular neurostimulation (tAN) system intended to provide non-invasi
• 00860005396962 - Sparrow Ascent Earpiece, Left: 2023-09-15 The Earpiece is a disposable component of the Sparrow Ascent and is designed to stay adhered to the skin of the left or right ea