NuvoMed

GUDID 00810110301436

DigiEars / LIGHT Bluetooth Neckband Hearing Aid

NUVOMED, INC.

Hearing aid neck induction loop, wireless input

• Primary Device ID: 00810110301436
• NIH Device Record Key: f13715e1-b622-4937-a5ba-1328db186a9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NuvoMed
• Version Model Number: HNB-4/0143
• Company DUNS: 080809709
• Company Name: NUVOMED, INC.
• 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: true
• Lot Batch: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810110301436 [Primary]

FDA Product Code

• QUG: Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter

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: 2022-11-23
• Device Publish Date: 2022-11-15

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• 00859811007407: Therapy Machine (Non-App)
• 00859811007391: Fingertips Oximeter
• 00859811007384: Arm Blood Pressure (Non-app)
• 00859811007377: Wrist Blood Pressure
• 00859811007360: Infrared Thermometer (Non-app)
• 00859811007261: Glucose Test Strip (Non-apps)
• 00859811007063: Glucose test strip
• 00859811007049: Wireless Blood Glucose Monitoring System
• 00859811007025: Wireless Infrared Thermometer
• 00859811007018: Automatic Blood Pressure Monitor
• 00859811007001: Wireless Finger Oxygen Saturation Monitor
• 00859811009258: Audible Fingertip Pulse Oximeter
• 00859811009241: Audible Infrared Thermometer
• 00859811009234: Audible Arm Blood Pressure Monitor (Non-app)
• 00810110301290: Portable Cordless Air Massager
• 00810110301443: DigiEars / PLUS Digital Behind-The-Ear Hearing Aid
• 00810110301436: DigiEars / LIGHT Bluetooth Neckband Hearing Aid
• 00810110301429: DigiEars / MAX Complete In-Canal Hearing Aid with Charging Case
• 00810110301412: DigiEars / PRO Digital True Wireless Hearing Aid
• 00810110301481: Atrial Fibrillation Blood Pressure Monitor
• 00810110301535: Portable EKG Monitor
• 00810110302075: Wrist Blood Pressure Monitor
• 00810110302129: Compression Hot & Cold Therapy Pad
• 00810110302112: Compression Hot & Cold Therapy Sleeve - XL
• 00810110302105: Compression Hot & Cold Therapy Sleeve - Large
• 00810110302099: Compression Hot & Cold Therapy Sleeve - Small
• 00810110303508: Arm Blood Pressure Monitor
• 00810110303492: Wrist Blood Pressure Monitor