Headset HB-8 8-75-790

GUDID 05713315005909

Headset HB-8, 12kHz matched TDH 39 phones, jack

Natus Medical Denmark ApS

Speech audiometer

• Primary Device ID: 05713315005909
• NIH Device Record Key: 606c3a3d-a535-4fec-87ef-dcad5487fa59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Headset HB-8
• Version Model Number: 8-75-790
• Catalog Number: 8-75-790
• Company DUNS: 306633756
• Company Name: Natus Medical Denmark ApS
• 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: false
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05713315005909 [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: 2025-05-26
• Device Publish Date: 2025-05-16

Devices Manufactured by Natus Medical Denmark ApS

• 05713315012075 - OAE Eartips: 2025-12-30 OAE Pediatric Foam Tip (20x)
• 05713315012082 - OAE Eartips: 2025-12-30 OAE Adult Foam Tip (20)
• 05713315012099 - OAE Eartips: 2025-12-30 OAE TreeTip (20)
• 05713315012105 - OAE Eartips: 2025-12-30 OAE Preemie TreeTip (20)
• 05713315012112 - OAE Eartips: 2025-12-30 OAE Jumbo Foam Tip (100)
• 05713315012129 - OAE Eartips: 2025-12-30 OAE Pediatric Foam Tip (100)
• 05713315012136 - OAE Eartips: 2025-12-30 OAE Adult Foam Tip (100)
• 05713315012143 - OAE Eartips: 2025-12-30 OAE TreeTip (100)