Bio-logic 101113

GUDID 00382830053662

Tiptrode Gold-Foil Foam Tip for Adults

NATUS MEDICAL INCORPORATED

Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer

• Primary Device ID: 00382830053662
• NIH Device Record Key: cb1b1a7e-8e02-497b-9d10-130a9e5aebb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bio-logic
• Version Model Number: Tiptrode Electrodes Adults
• Catalog Number: 101113
• Company DUNS: 962519208
• Company Name: NATUS MEDICAL INCORPORATED
• Device Count: 20
• 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: true
• Lot Batch: true
• Serial Number: false
• 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
• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com
• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com
• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com
• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com
• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com
• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com
• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com
• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com
• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com
• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com
• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com
• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com
• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com
• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com
• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com
• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com
• Phone: 1-800-303-0306
• Email: BLSC_Hearing_Support@natus.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382830053662 [Primary]
GS1	00382830054195 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030823

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: 2017-03-31

On-Brand Devices [Bio-logic]

• 00382830053662: Tiptrode Gold-Foil Foam Tip for Adults
• 00382830053655: Tiptrode Gold-Foil Foam Tip for Pediatric
• 00382830053341: Standard Insert Earphone, 12 feet cable.
• 00382830053334: Abaer Standard Insert Earphone, 12 feet cable
• 00382830053327: Standard Insert Earphone, 8 feet cable
• 00382830053181: The Bio-logic Navigator Pro AEP system is indicated for use in the recording and display of huma
• 00382830052504: OAE Jumbo Tip
• 00382830052467: The Bio-logic Insert Earphones are accessories to the Bio-logic ABaer / Navigator Pro Auditory E
• 00382830052313: ER2 replacement plastic tips for use with 580-ER2INS
• 00382830052306: ER2/Broadband Insert Earphone Disposable Foam Tips for adults and for use with 580-ER2INS
• 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
• 00382830052214: Insert Earphone Foam Tips, Jumbo
• 00382830052207: Disposable Insert Earphone Foam Tips for Adult
• 00382830052191: Foam Tips Insert Earphone, Pediatric
• 00382830052177: Disposable Subdermal Needle Electrode 1M
• 00382830047074: Silver-Chloride Ear Clip Electrode, Pediatric, 6 mm
• 00382830001427: Disposable Snap Electrodes
• 00382830001090: The ABaer Hearing Screening System performs automated objective hearing screening utilizing audi
• 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