Carewell

GUDID 06971049340706

Shenzhen Carewell Electronics Co., Ltd.

Electrocardiograph, professional, multichannel

• Primary Device ID: 06971049340706
• NIH Device Record Key: dfc9463d-0db0-4a0b-b1c3-4910208d5742
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Carewell
• Version Model Number: ECG-1112D
• Company DUNS: 545331373
• Company Name: Shenzhen Carewell Electronics 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: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971049340706 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113485

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: 2
• Public Version Date: 2020-02-10
• Device Publish Date: 2020-01-01

On-Brand Devices [Carewell]

• 06971049340706: ECG-1112D
• 06971049340690: ECG-1112
• 06971049340683: ECG-1106L
• 06971049340676: ECG-1103LW(I)
• 06971049340669: ECG-1103G(I)
• 06971049340652: ECG-1101G(I)