Caring Mill by Aura Serene

GUDID 00085526400862

Caring Mill by Aura Serene Menstrual Relief Tens Device

Aura Medical

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 00085526400862
• NIH Device Record Key: 0d1676bc-0415-4601-be62-f3dd17723d0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Caring Mill by Aura Serene
• Version Model Number: SR40
• Company DUNS: 052076745
• Company Name: Aura Medical
• 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: false
• Manufacturing Date: false
• 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	00085526400862 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190009

FDA Product Code

• NUH: Stimulator, Nerve, Transcutaneous, 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: 2024-11-22
• Device Publish Date: 2024-11-14

Devices Manufactured by Aura Medical

• 00085526400862 - Caring Mill by Aura Serene: 2024-11-22Caring Mill by Aura Serene Menstrual Relief Tens Device
• 00085526400862 - Caring Mill by Aura Serene: 2024-11-22 Caring Mill by Aura Serene Menstrual Relief Tens Device
• 00863943000120 - Aura Medical: 2020-02-24