NONE

GUDID 06974239702919

Guangzhou Daxin health technology Co.,Ltd

Automatic-inflation electronic sphygmomanometer, non-portable

• Primary Device ID: 06974239702919
• NIH Device Record Key: bffd16e1-35de-4760-a111-ef3ef0977e93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NONE
• Version Model Number: ePA-46B
• Company DUNS: 722481840
• Company Name: Guangzhou Daxin health 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: true
• 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	06974239702919 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K134029

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-18
• Device Publish Date: 2025-07-10

Devices Manufactured by Guangzhou Daxin health technology Co.,Ltd

• 06974239702919 - NONE: 2025-07-18
• 06974239702919 - NONE: 2025-07-18
• 06974239702902 - EQUATE: 2025-05-22
• 16974239700677 - FOXXD: 2024-10-04
• 16974239700660 - Sealy: 2024-09-20
• 16974239700646 - FOXXD: 2024-08-09
• 16974239700653 - FOXXD: 2024-08-09
• 06974239702841 - innotech: 2024-04-05
• 16974239700639 - innotech: 2024-04-05