MIRACLE-EAR

GUDID 00840388205198

STARKEY LABORATORIES, INC.

Tinnitus masking application software

• Primary Device ID: 00840388205198
• NIH Device Record Key: 5c80384f-47aa-449d-9f6f-f2b529986ac3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIRACLE-EAR
• Version Model Number: MIRACLE-EAR MEENERGY 5 ITC R 6S|ST
• Company DUNS: 055461479
• Company Name: STARKEY LABORATORIES, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840388205198 [Primary]

FDA Product Code

• OSM: Hearing Aid, Air-Conduction with Wireless Technology, Prescription

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: 2024-12-09
• Device Publish Date: 2024-11-29

On-Brand Devices [MIRACLE-EAR]

• 00840388206218: MIRACLE-EAR MEENERGY 5 RIC R 6S|ST (DEMO)
• 00840388205662: MIRACLE-EAR MEENERGY 2 HS R 6S|ST
• 00840388205600: MIRACLE-EAR MEENERGY 3 HS R 6S|ST
• 00840388205549: MIRACLE-EAR MEENERGY 4 HS R 6S|ST
• 00840388205495: MIRACLE-EAR MEENERGY 5 HS R 6S|ST
• 00840388205426: MIRACLE-EAR MEENERGY 2 ITC R 6S|ST
• 00840388205341: MIRACLE-EAR MEENERGY 3 ITC R 6S|ST
• 00840388205266: MIRACLE-EAR MEENERGY 4 ITC R 6S|ST
• 00840388205198: MIRACLE-EAR MEENERGY 5 ITC R 6S|ST
• 00840388205105: MIRACLE-EAR MEENERGY 2 ITE R 6S|ST
• 00840388205037: MIRACLE-EAR MEENERGY 3 ITE R 6S|ST
• 00840388204962: MIRACLE-EAR MEENERGY 4 ITE R 6S|ST
• 00840388204900: MIRACLE-EAR MEENERGY 5 ITE R 6S|ST
• 00840388204825: MIRACLE-EAR MEMINI 2 CIC 312 6S|ST
• 00840388204719: MIRACLE-EAR MEMINI 3 CIC 312 6S|ST
• 00840388204627: MIRACLE-EAR MEMINI 4 CIC 312 6S|ST
• 00840388204542: MIRACLE-EAR MEMINI 5 CIC 312 6S|ST
• 00840388204436: MIRACLE-EAR MECONNECT 3 RIC 312 6S|ST
• 00840388204313: MIRACLE-EAR MECONNECT 4 RIC 312 6S|ST
• 00840388204238: MIRACLE-EAR MECONNECT RIC 312 6S|ST (TIER DEMO)
• 00840388204146: MIRACLE-EAR MECONNECT 5 RIC 312 6S|ST (DEMO)
• 00840388204054: MIRACLE-EAR MECROS RIC 312 6S ST
• 00840388203972: MIRACLE-EAR MECONNECT 5 RIC 312 6S|ST
• 00840388203897: MIRACLE-EAR MEENERGY 3 RIC R-S 6S|ST
• 00840388203774: MIRACLE-EAR MEENERGY 4 RIC R-S 6S|ST
• 00840388203699: MIRACLE-EAR MEENERGY 5 RIC R-S 6S|ST (TIER DEMO)
• 00840388203583: MIRACLE-EAR MEENERGY 5 RIC R-S 6S|ST (DEMO)
• 00840388203477: MIRACLE-EAR MEENERGY 5 RIC R-S 6S|ST
• 00840388203385: MIRACLE-EAR MEENERGY 3 RIC R 6S|ST
• 00840388203255: MIRACLE-EAR MEENERGY 4 RIC R 6S|ST
• 00840388203170: MIRACLE-EAR MEENERGY 5 RIC R 6S|ST (TIER DEMO)
• 00840388203163: MIRACLE-EAR MECROS RIC R 6S|ST
• 00840388203095: MIRACLE-EAR MEENERGY 5 RIC R 6S|ST
• 00842318199669: MIRACLE EAR MEMINI 2 CIC 312
• 00842318199553: MIRACLE EAR MEMINI 3 CIC 312
• 00842318199447: MIRACLE EAR MEMINI 4 CIC 312
• 00842318199331: MIRACLE EAR MEMINI 5 CIC 312
• 00842318199133: MIRACLE-EAR MECONNECT DEMO RIC 312
• 00842318198860: MEENERGY 5 RIC R-S BL (TIER DEMO) (TIER DEMO)
• 00842318198754: MEENERGY RIC R BL (TIER DEMO) (TIER DEMO)
• 00842318198662: MIRACLE-EAR BLISS CROS RIC RT
• 00842318198631: MIRACLE-EAR BLISS 2 MRIC R
• 00842318198600: MIRACLE-EAR BLISS 3 MRIC R
• 00842318198570: MIRACLE-EAR BLISS 4 MRIC R
• 00842318198549: MIRACLE-EAR BLISS 2 RIC RT
• 00842318198525: MIRACLE-EAR BLISS 3 RIC RT
• 00842318198501: MIRACLE-EAR BLISS 4 RIC RT
• 00842318198488: MIRACLE-EAR BLISS 5 MRIC R
• 00842318198440: MIRACLE-EAR BLISS 5 RIC RT
• 00842318198419: Miracle-EarMINI 2 CIC 10 BL