Natus 8-49-88800

GUDID 05713315008672

Acculink Software

Gn Otometrics A/S

Evoked-potential audiometer

• Primary Device ID: 05713315008672
• NIH Device Record Key: 96d1f559-150c-486d-b3ce-8044180e3f2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Natus
• Version Model Number: 8-49-88800
• Catalog Number: 8-49-88800
• Company DUNS: 306633756
• Company Name: Gn Otometrics A/S
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05713315008672 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132957

FDA Product Code

• GWJ: Stimulator, Auditory, Evoked Response

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: 2020-12-25
• Device Publish Date: 2020-12-17

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