Friendship Medical

GUDID 16955739020564

Xi'an Friendship Medical Electronics Co.,Ltd.

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• Primary Device ID: 16955739020564
• NIH Device Record Key: 2a7b1f62-39c1-4486-9c2a-8df8ad9c1bf6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Friendship Medical
• Version Model Number: SEAg-S-2500/10
• 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	06955739020567 [Unit of Use]
GS1	16955739020564 [Primary]
GS1	26955739020561 [Package]; 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: 2021-01-01
• Device Publish Date: 2020-12-24