Miracle-Ear 10966404

GUDID 04056839103784

Miracle-Ear HA IRHYTHM ME4500 L3 WHT Hearing Aid

SIVANTOS, INC.

Behind-the-ear air-conduction hearing aid

• Primary Device ID: 04056839103784
• NIH Device Record Key: 46fca5a9-de39-4987-bb68-ce4a739bb004
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Miracle-Ear
• Version Model Number: HA IRHYTHM ME4500 L3 WHT
• Catalog Number: 10966404
• Company DUNS: 157412271
• Company Name: SIVANTOS, 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056839103784 [Primary]

FDA Product Code

• OSM: Hearing Aid, Air Conduction With Wireless Technology

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: 2019-04-19
• Device Publish Date: 2019-04-11

On-Brand Devices [Miracle-Ear]

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• 04056839160756: Miracle-Ear HA ME 2275 P SLV Hearing Aid
• 04056839160749: Miracle-Ear HA ME 2275 P GR Hearing Aid
• 04056839160732: Miracle-Ear HA ME 2275 P DGT Hearing Aid
• 04056839160725: Miracle-Ear HA ME 2275 P BRN Hearing Aid
• 04056839160718: Miracle-Ear HA ME 2275 P BLK Hearing Aid
• 04056839160701: Miracle-Ear HA ME 2275 P BG Hearing Aid
• 04056839160695: Miracle-Ear HA ME 2275 S SLV Hearing Aid
• 04056839160688: Miracle-Ear HA ME 2275 S GR Hearing Aid
• 04056839160671: Miracle-Ear HA ME 2275 S DGT Hearing Aid
• 04056839160664: Miracle-Ear HA ME 2275 S BRN Hearing Aid
• 04056839160657: Miracle-Ear HA ME 2275 S BLK Hearing Aid
• 04056839160640: Miracle-Ear HA ME 2275 S BG Hearing Aid
• 04056839160633: Miracle-Ear HA ME 2275 M SLV Hearing Aid
• 04056839160626: Miracle-Ear HA ME 2275 M GR Hearing Aid
• 04056839160619: Miracle-Ear HA ME 2275 M BRN Hearing Aid
• 04056839160602: Miracle-Ear HA ME 2275 M BLK Hearing Aid
• 04056839160596: Miracle-Ear HA ME 2275 M BG Hearing Aid
• 04056839160589: Miracle-Ear HA ME 2275 M DGT Hearing Aid
• 04056839160503: Miracle-Ear HA ME 3300 MINI RIC SLV Hearing Aid
• 04056839160497: Miracle-Ear HA ME 3300 MINI RIC SB Hearing Aid
• 04056839160480: Miracle-Ear HA ME 3300 MINI RIC PRL Hearing Aid
• 04056839160473: Miracle-Ear HA ME 3300 MINI RIC GR Hearing Aid
• 04056839160466: Miracle-Ear HA ME 3300 MINI RIC GNT Hearing Aid
• 04056839160459: Miracle-Ear HA ME 3300 MINI RIC Hearing Aid
• 04056839160442: Miracle-Ear HA ME 3300 MINI RIC BLK Hearing Aid
• 04056839160435: Miracle-Ear HA ME 3300 MINI RIC BG Hearing Aid
• 04056839160428: Miracle-Ear HA ME5300 SX SLV Hearing Aid
• 04056839160411: Miracle-Ear HA ME5300 SX GR Hearing Aid
• 04056839160404: Miracle-Ear HA ME5300 SX GNT Hearing Aid
• 04056839160398: Miracle-Ear HA ME5300 SX GB Hearing Aid
• 04056839160381: Miracle-Ear HA ME5300 SX C12 Hearing Aid
• 04056839160374: Miracle-Ear HA ME5300 SX BRN Hearing Aid
• 04056839160367: Miracle-Ear HA ME5300 SX BLK Hearing Aid
• 04056839160350: Miracle-Ear HA ME4300 SX SLV Hearing Aid
• 04056839160343: Miracle-Ear HA ME4300 SX GR Hearing Aid
• 04056839160336: Miracle-Ear HA ME4300 SX GNT Hearing Aid
• 04056839160329: Miracle-Ear HA ME4300 SX GB Hearing Aid
• 04056839160312: Miracle-Ear HA ME4300 SX C12 Hearing Aid
• 04056839160305: Miracle-Ear HA ME4300 SX BRN Hearing Aid
• 04056839160299: Miracle-Ear HA ME4300 SX BLK Hearing Aid
• 04056839160282: Miracle-Ear HA ME4300 SX BG Hearing Aid
• 04056839160275: Miracle-Ear HA ME3300 SX SLV Hearing Aid
• 04056839160268: Miracle-Ear HA ME3300 SX GR Hearing Aid
• 04056839160251: Miracle-Ear HA ME3300 SX GNT Hearing Aid
• 04056839160244: Miracle-Ear HA ME3300 SX GB Hearing Aid
• 04056839160237: Miracle-Ear HA ME3300 SX C12 Hearing Aid
• 04056839160220: Miracle-Ear HA ME3300 SX BRN Hearing Aid
• 04056839160213: Miracle-Ear HA ME3300 SX BLK Hearing Aid