Natus 8-31-19002

GUDID 05713315008627

Patient Responder (Blue)

Gn Otometrics A/S

Pure-tone audiometer

• Primary Device ID: 05713315008627
• NIH Device Record Key: 7fb15426-5ddb-4cb5-8aae-5ea066eba1bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Natus
• Version Model Number: 8-31-19002
• Catalog Number: 8-31-19002
• Company DUNS: 306633756
• Company Name: Gn Otometrics A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05713315008627 [Primary]

FDA Product Code

• EWO: Audiometer

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: 2020-12-24
• Device Publish Date: 2020-12-16

On-Brand Devices [Natus ]

• 05713315008436: 1093 Desktop Cradle
• 05713315008429: 1093 HS3 Headset
• 05713315005992: 1093, DESKTOP CRADLE, ACCESSORY
• 05713315008627: Patient Responder (Blue)
• 05713315008610: Patient Responder (Black)
• 05713315008603: Patient Responder (Red)
• 05713315008672: Acculink Software
• 05713315008658: AccuScreen PRO Ear Couplers (25 sets of 2)
• 05713315008641: AccuScreen Ear Couplers (25 sets of 2)
• 05713315008689: 1053 Freefit Charger
• 05713315009051: Aurical Freefit without charger (Japan only)
• 05713315009044: Aurical Freefit without charger (China only)
• 05713315009037: Aurical Freefit with charger (China only)
• 05713315005893: HB 8 kHz headset, jack connector