HOMIEE

GUDID 06948158404469

SHENZHEN COMBEI TECHNOLOGY CO.,LTD

Automatic-inflation electronic sphygmomanometer, non-portable

• Primary Device ID: 06948158404469
• NIH Device Record Key: 93056652-1dcf-4251-9abe-62fb6c23c41e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HOMIEE
• Version Model Number: BP1003
• Company DUNS: 529383632
• Company Name: SHENZHEN COMBEI 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06948158404469 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181104

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-04-22

On-Brand Devices [HOMIEE]

• 06948158403936: BP2001
• 06948158403912: BP1002
• 06948158403905: BP1001
• 06948158404452: BP1001
• 06948158404469: BP1003