Digital Electrocardiograph

GUDID 06937683412377

Shenzhen Biocare Bio-Medical Equipment Co., Ltd.

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• Primary Device ID: 06937683412377
• NIH Device Record Key: 46d61b46-5f76-46a8-8c01-2db6d29f0443
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Digital Electrocardiograph
• Version Model Number: iE300
• Company DUNS: 529081176
• Company Name: Shenzhen Biocare Bio-Medical Equipment 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: 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	06937683412377 [Primary]
GS1	06937683490115 [Package]; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160092

FDA Product Code

• DPS: Electrocardiograph

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: 2018-07-06
• Device Publish Date: 2016-10-18

On-Brand Devices [Digital Electrocardiograph]

• 06937683415125: iE15
• 06937683414319: iE6
• 06937683413879: iE10
• 06937683413329: ECG-1210
• 06937683413022: iE12
• 06937683412520: ECG-3010
• 06937683412377: iE300
• 06937683412346: iE3
• 06937683411530: iE 12A
• 06937683411448: iE101
• 06937683490092: ECG-2000