Sparrow Ascent Earpiece, Right

GUDID 00850052017019

The Earpiece is a disposable component of the Sparrow Ascent and is designed to stay adhered to the skin of the left or right ear for up to 24 hours of electrical connectivity. The Inner Electrode interfaces with the cymba concha and the Outer Electrode interfaces with the trigeminal nerve. The Back Electrode is the return Electrode for both the Inner and Outer Electrodes.

Spark Biomedical Inc.

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

• Primary Device ID: 00850052017019
• NIH Device Record Key: b8c0b73b-c4ba-4708-ba4c-fb6871f63048
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sparrow Ascent Earpiece, Right
• Version Model Number: 211
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 100 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850052017002 [Package]; Package: Box [7 Units]; In Commercial Distribution
GS1	00850052017019 [Primary]
GS1	00850052017057 [Package]; Package: Box [28 Units]; In Commercial Distribution

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: 2023-09-15The Earpiece is a disposable component of the Sparrow Ascent and is designed to stay adhered to the skin of the left or right ear for up to 24 hours of electrical connectivity. The Inner Electrode interfaces with the cymba concha and the Outer Electrode interfaces with the trigeminal nerve. The Back Electrode is the return Electrode for both the Inner and Outer Electrodes.
• 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