FREMSLIFE 800-000-056

GUDID 08055765540010

FREMSLIFE SRL

Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: 08055765540010
• NIH Device Record Key: 90a46129-855c-4d5c-b6f4-53bc4bfcbb58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FREMSLIFE
• Version Model Number: APTI-GEL 800-000-056
• Catalog Number: 800-000-056
• Company DUNS: 435784260
• Company Name: FREMSLIFE SRL
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	08055765540010 [Primary]
GS1	18055765540017 [Package]; Package: [50 Units]; In Commercial Distribution
GS1	28055765540014 [Package]; Contains: 18055765540017; Package: [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080902

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-02-19
• Device Publish Date: 2018-01-28