yonker

GUDID 06921745200163

Wrist type Blood Pressure Monitor

Xuzhou Yongkang Electronic Science Technology Co., Ltd

Pulse oximeter, battery-powered Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter

• Primary Device ID: 06921745200163
• NIH Device Record Key: 18ca2c8b-b8c6-49de-86ab-a79dc1d05568
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: yonker
• Version Model Number: YK-BPW1
• Company DUNS: 542753796
• Company Name: Xuzhou Yongkang Electronic Science Technology Co., Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• 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	06921745200163 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162616

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: 2019-01-11
• Device Publish Date: 2018-12-11

On-Brand Devices [yonker]

• 06921745200255: Fingertip Pulse Oximeter
• 06921745200163: Wrist type Blood Pressure Monitor
• 06921745200033: Fingertip Pulse Oximeter
• 06921745200026: Fingertip Pulse Oximeter
• 06921745200156: YK-BPA1