Earlens Charger CHEL101

GUDID 00850013007035

EARLENS CORPORATION

Noninvasive device battery charger

• Primary Device ID: 00850013007035
• NIH Device Record Key: 918b1e8c-34fe-4491-a6eb-fa426c63a9d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Earlens Charger
• Version Model Number: CHEL101
• Catalog Number: CHEL101
• 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 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850013007035 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2020-05-07
• Device Publish Date: 2016-09-24

On-Brand Devices [Earlens Charger]

• 08500130070031: CHEL101
• 00850013007035: CHEL101