Bio-logic 580-SINSER-008

GUDID 00382830053327

Standard Insert Earphone, 8 feet cable

NATUS MEDICAL INCORPORATED

Auditory stimulator

• Primary Device ID: 00382830053327
• NIH Device Record Key: b539c6ff-b949-4d92-9b42-fdec2d07563d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bio-logic
• Version Model Number: Standard Insert Earphone 8 ft
• Catalog Number: 580-SINSER-008
• Company DUNS: 962519208
• Company Name: NATUS MEDICAL INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com
• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com

Device Dimensions

• Length: 8 Feet
• Length: 8 Feet

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382830053327 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031352

FDA Product Code

• EWO: Audiometer

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-04-04

On-Brand Devices [Bio-logic]

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• 00382830052290: ER2/Broadband Insert Earphone Disposable Foam Tips for pediatric and for use with 580-ER2INS
• 00382830052283: Replacement Sinser Tips, white, for use with 580-SINSER insert earphones
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• 00382830001427: Disposable Snap Electrodes
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• 00382830001038: Halo EarMuffin Adapter Tube for use with 580-SINSER insert earphone
• 00382830001007: Infant Tip Adapter for use with 580-SINSER Insert Earphones
• 00382830000987: Halo Ear Muffins with Tab Electrodes
• 00382830000840: OAE 6mm Blue Ear Tip
• 00382830000833: OAE 6mm Blue Ear Tip
• 00382830000826: OAE Preemie TreeTip
• 00382830000819: OAE TreeTip
• 00382830000796: OAE Adult Foam Tip
• 00382830000789: OAE Pediatric Foam Ear Tip
• 00382830000772: OAE Jumbo Foam Tip
• 00382830000765: OAE Preemie TreeTip
• 00382830000758: OAE Tree Tip
• 00382830000741: OAE Adult Foam Tip
• 00382830000734: OAE Pediatric Foam Ear Tip
• 00382830000543: OAE Ear Probe Assembly