Earlens Ear Tip, Left ET01L

GUDID 00850013007547

EARLENS CORPORATION

Tympanic membrane contact hearing aid ear tip transmitter

• Primary Device ID: 00850013007547
• NIH Device Record Key: 536843cd-d379-4814-bcfe-c8042975835e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Earlens Ear Tip, Left
• Version Model Number: ET01L
• Catalog Number: ET01L
• Company DUNS: 611658795
• Company Name: EARLENS CORPORATION
• 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: 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 -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 525 Millimeter of Mercury and 795 Millimeter of Mercury
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 525 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 525 Millimeter of Mercury and 795 Millimeter of Mercury
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 525 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 525 Millimeter of Mercury and 795 Millimeter of Mercury
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 525 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 525 Millimeter of Mercury and 795 Millimeter of Mercury
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 525 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 525 Millimeter of Mercury and 795 Millimeter of Mercury
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 525 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 525 Millimeter of Mercury and 795 Millimeter of Mercury
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 525 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 525 Millimeter of Mercury and 795 Millimeter of Mercury
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 525 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 525 Millimeter of Mercury and 795 Millimeter of Mercury
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 525 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 525 Millimeter of Mercury and 795 Millimeter of Mercury
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 525 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 525 Millimeter of Mercury and 795 Millimeter of Mercury
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 525 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 525 Millimeter of Mercury and 795 Millimeter of Mercury
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 525 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 525 Millimeter of Mercury and 795 Millimeter of Mercury
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 525 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 525 Millimeter of Mercury and 795 Millimeter of Mercury
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 525 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 525 Millimeter of Mercury and 795 Millimeter of Mercury
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 525 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 525 Millimeter of Mercury and 795 Millimeter of Mercury
• Handling Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 525 Millimeter of Mercury and 795 Millimeter of Mercury

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850013007547 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182480

FDA Product Code

• PLK: Tympanic Membrane Direct Contact Hearing Aid

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: 2023-06-19
• Device Publish Date: 2023-06-09

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• 00850013007516 - Earlens Processor, Champagne: 2023-06-19
• 00850013007523 - Earlens Processor, Silver: 2023-06-19
• 00850013007530 - Earlens Processor, Black: 2023-06-19
• 00850013007547 - Earlens Ear Tip, Left: 2023-06-19
• 00850013007547 - Earlens Ear Tip, Left: 2023-06-19
• 00850013007554 - Earlens Ear Tip, Right: 2023-06-19
• 00850013007561 - Earlens Tympanic Lens, Left: 2023-06-19