Echo-Screen Hearing Screening Supplies 1630-25-US

GUDID 00382830051231

25 sets of Echo-Screen II Ear Couplers and 25 sets of Snap Electrodes.

NATUS MEDICAL INCORPORATED

Ear simulator, acoustic coupler

• Primary Device ID: 00382830051231
• NIH Device Record Key: 7cab5d27-03b0-43ec-8940-746a25afd6c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Echo-Screen Hearing Screening Supplies
• Version Model Number: Echo-PAK
• Catalog Number: 1630-25-US
• Company DUNS: 962519208
• Company Name: NATUS MEDICAL INCORPORATED
• Device Count: 50
• 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00382830051231 [Primary]
GS1	00382830053266 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013977

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: 2017-01-06

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