Sparrow Ascent 28 Piece Kit (B2C)

GUDID 00850052017088

A starter pack with all the components for acute withdrawal management using Transcutaneous Auricular Neurostimulation (tAN®). This pack includes the Sparrow Ascent Kit and three Sparrow Ascent Left Earpiece Kits. (1) GTIN: 00860005396986 (Base kit containing the Patient Controller, Cable, Belt Clip, QSG, Batteries, seven Alcohol Wipes, and seven Left Earpieces) (3) GTIN: 00860005396993

Spark Biomedical Inc.

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

• Primary Device ID: 00850052017088
• NIH Device Record Key: d473e168-f8b2-4497-be2e-86d43eaab33e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sparrow Ascent 28 Piece Kit (B2C)
• Version Model Number: 11-310-K-28
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850052017088 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230796

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): 2023-09-15A starter pack with all the components for acute withdrawal management using Transcutaneous Auricular Neurostimulation (tAN®). This pack includes the Sparrow Ascent Kit and three Sparrow Ascent Left Earpiece Kits. (1) GTIN: 00860005396986 (Base kit containing the Patient Controller, Cable, Belt Clip, QSG, Batteries, seven Alcohol Wipes, and seven Left Earpieces) (3) GTIN: 00860005396993
• 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