Caremed EHPU585-A

GUDID 06970758507677

Caremed ECG lead wire

Shenzhen Caremed Medical Technology Co., Ltd.

Electrocardiographic lead set, reusable

• Primary Device ID: 06970758507677
• NIH Device Record Key: 68c85eec-8096-4848-bd8c-70b8efdf6a0a
• Commercial Distribution Discontinuation: 2019-10-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Caremed
• Version Model Number: EHPU585-A
• Catalog Number: EHPU585-A
• Company DUNS: 544335718
• Company Name: Shenzhen Caremed Medical Technology Co., Ltd.
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970758507677 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153188

FDA Product Code

• DSA: Cable, Transducer And Electrode, Patient, (Including Connector)

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: 2019-11-08
• Device Publish Date: 2019-10-31

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