E+R

GUDID 01697038425005

HONSUN (NANTONG) CO.,LTD

Automatic-inflation electronic sphygmomanometer, portable, finger

• Primary Device ID: 01697038425005
• NIH Device Record Key: 5ba63bd7-d1b7-4a09-801f-068accd2473f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E+R
• Version Model Number: LD-737
• Company DUNS: 543364560
• Company Name: HONSUN (NANTONG) CO.,LTD
• Device Count: 40
• 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: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	01697038425005 [Unit of Use]
GS1	11697038425002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131463

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: 2020-10-05
• Device Publish Date: 2020-09-27

Devices Manufactured by HONSUN (NANTONG) CO.,LTD

• 16970384254515 - /: 2024-09-17
• 06970384250800 - Take a breath: 2022-04-08
• 06970384250961 - SCIAN: 2022-04-08
• 06970384250176 - SCIAN: 2022-04-08
• 06970384250183 - SCIAN: 2022-04-08
• 06970384250213 - SCIAN: 2022-04-08
• 06970384250220 - HONSUN: 2022-04-08
• 06970384250435 - SCIAN: 2022-04-08