Nalu Medical, Inc. 74002-US

GUDID 00812537036786

Nalu User's Trial Kit

NALU MEDICAL, INC.

Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator

• Primary Device ID: 00812537036786
• NIH Device Record Key: 6edf5ce3-ea9c-4700-82e3-3feb98092dfb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nalu Medical, Inc.
• Version Model Number: 74002-US
• Catalog Number: 74002-US
• Company DUNS: 067140761
• Company Name: NALU MEDICAL, 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com
• Phone: 1-800-618-3402
• Email: info@nalumed.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 107 KiloPascal
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812537036786 [Primary]

FDA Product Code

• GZF: Stimulator, Peripheral Nerve, Implanted (Pain Relief)

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: 2022-02-03
• Device Publish Date: 2022-01-26

On-Brand Devices [Nalu Medical, Inc.]

• 00812537032313: Lead Blank, 50 cm
• 00812537032672: Limb Cuff, Large (Black)
• 00812537032634: Limb Cuff (Black)
• 00812537032597: Relief Belt (Black)
• 00812537032535: Adhesive Test Patch Pack
• 00812537032511: Adhesive Clip Pack (H300)
• 00812537032498: Adhesive Clip Pack (H100)
• 00812537032474: Adhesive Clip Pack (H200)
• 00812537035574: Stylet (straight, 30 cm)
• 00812537032955: Lead Kit (4 contact, 40 cm, Tined)
• 00812537032924: Nalu Neurostimulation Kit (Integrated, Single 4, 40 cm, Tined)
• 00812537031057: Lead Kit (4 contact, 25 cm, Tined)
• 00812537031040: Lead Extension Kit (4)
• 00812537030999: Nalu Neurostimulation Kit (Ported, Single 4)
• 00812537030982: Nalu Neurostimulation Kit (Integrated, Single 4, 25 cm, Tined)
• 00812537030944: Nalu Neurostimulation Kit (Integrated, Dual 8, 40 cm)
• 00812537031934: Trial Lead (8 contact, 60 cm)
• 00812537035680: Peripheral Nerve Stimulation Lead (8 contact, 60 cm)
• 00812537035666: Peripheral Nerve Stimulation Lead (8 contact, 40 cm)
• 00812537035642: Peripheral Nerve Stimulation Lead Kit (8 contact, 60 cm)
• 00812537035628: Peripheral Nerve Stimulation Lead Kit (8 contact, 40 cm)
• 00812537035604: Nalu Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm)
• 00812537033013: SCS Remote App (compatible with iOS)
• 00812537032863: Nalu Neurostimulation User's Kit
• 00812537032832: Nalu User's Trial Kit
• 00812537032566: Clinician Programmer
• 00812537032450: EIC Extension
• 00812537032436: EIC
• 00812537032290: Stylet (straight, 65 cm)
• 00812537032276: Stylet (Straight, 45 cm)
• 00812537032153: Straw Tunneler
• 00812537032139: IPG Insertion Tool
• 00812537032115: Torque Wrench
• 00812537032092: Pocket Tunneler
• 00812537032078: Tearaway introducer assembly (14 cm sheath)
• 00812537032054: Tearaway introducer assembly (10 cm sheath)
• 00812537032030: Stylet (Bent, 65 cm)
• 00812537032016: Stylet (Bent, 45 cm)
• 00812537031996: Spoonbill Needle (6"/15 cm)
• 00812537031972: Spoonbill Needle (4.5"/11 cm)
• 00812537031958: Anchor
• 00812537031859: Lead Extension (8 contact, 60 cm)
• 00812537031835: Lead (8 contact, 60 cm)
• 00812537031811: Lead (8 contact, 40 cm)
• 00812537031033: Lead Extension Kit (8)
• 00812537031026: Trial Lead Kit (8 contact, 60 cm)
• 00812537031019: Lead Kit (8 contact, 60 cm)
• 00812537031002: Lead Kit (8 contact, 40 cm)
• 00812537030975: Nalu Neurostimulation Kit (Ported, Dual 8, 40 cm)
• 00812537030968: Nalu IPG Kit (Ported, Dual 8)