NATUS MEDICAL

GUDID 00382830044615

Echo-Screen III Pro Hearing Screening Device TEOAE and DPOAE set

NATUS MEDICAL INCORPORATED

Evoked-potential audiometer

• Primary Device ID: 00382830044615
• NIH Device Record Key: 565047c2-a124-4f78-b046-361e8fe41d5a
• Commercial Distribution Discontinuation: 2017-04-20
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: NATUS MEDICAL
• Version Model Number: 013504
• 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: true
• 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: Technical.Service@natus.com
• Phone: 1-800-303-0306
• Email: Technical.Service@natus.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382830044615 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141446

FDA Product Code

• GWJ: Stimulator, Auditory, Evoked Response

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: 2016-10-26

On-Brand Devices [NATUS MEDICAL]

• 00382830044738: PCA Electrode Cable for Echo-Screen III Devices
• 00382830044721: ATA Transducer for Echo-Screen III Devices
• 00382830044660: Echo-Screen III Pro Hearing Screening Device TEOAE, DPOAE and ABR set w/o Barcode Scanner
• 00382830044653: Echo-Screen III Pro Hearing Screening Device TEOAE, DPOAE and ABR set
• 00382830044646: Echo-Screen III Pro Hearing Screening Device DPOAE and ABR set w/o Barcode Scanner
• 00382830044639: Echo-Screen III Pro Hearing Screening Device DPOAE and ABR set
• 00382830044622: Echo-Screen III Pro Hearing Screening Device TEOAE and ABR set w/o Barcode Scanner
• 00382830044615: Echo-Screen III Pro Hearing Screening Device TEOAE and DPOAE set
• 00382830044608: Echo-Screen III Pro Hearing Screening Device TEOAE and DPOAE set w/o Barcode Scanner
• 00382830044592: Echo-Screen III Pro Hearing Screening Device TEOAE and DPOAE set
• 00382830044585: Echo-Screen III Pro Hearing Screening Device ABR set w/o Barcode Scanner
• 00382830044578: Echo-Screen III Pro Hearing Screening Device ABR set
• 00382830044561: Echo-Screen III Pro Hearing Screening Device DPOAE set w/o Barcode Scanner
• 00382830044554: Echo-Screen III Pro Hearing Screening Device DPOAE set
• 00382830044547: Echo-Screen III Pro Hearing Screening Device TEOAE set w/o Barcode Scanner
• 00382830044530: Echo-Screen III Pro Hearing Screening Device - TEOAE set with Barcode Scanner
• 00382830044066: ALGO 3i Patient Connection Assembly (PCA) Long Cable
• 00382830044059: Preamplifier 3 Cable
• 00382830044042: Patient Cable Assembly (PCA) Cable
• 00382830044035: ALGO 3i Acoustic Transducer Assembly (ATA) Cable
• 00382830044028: ALGO 3i Preamplifier, Short Length
• 00382830043977: ALGO 5 Pre-Amplifier Cable
• 00382830043960: ALGO 5 Patient Cable Assembly (PCA) Cable
• 00382830043915: ALGO 5 US ACCESSORY BOX
• 00382830000727: OAE Jumbo Ear Tips - qty 20