Cadwell

GUDID 26955739000037

Xi'an Friendship Medical Electronics Co.,Ltd.

Electrode conductive medium

• Primary Device ID: 26955739000037
• NIH Device Record Key: 393f1923-8bf9-4667-9bbe-48b741641845
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cadwell
• Version Model Number: 302851-000-100
• Company DUNS: 529249095
• Company Name: Xi'an Friendship Medical Electronics Co.,Ltd.
• Device Count: 4
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06955739000033 [Unit of Use]
GS1	16955739000030 [Primary]
GS1	26955739000037 [Package]; Contains: 16955739000030; Package: Box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110289

FDA Product Code

• GXY: Electrode, Cutaneous

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: 2022-05-02
• Device Publish Date: 2022-04-24