yonker

GUDID 06921745200026

Fingertip Pulse Oximeter

Xuzhou Yongkang Electronic Science Technology Co., Ltd

Pulse oximeter, battery-powered

• Primary Device ID: 06921745200026
• NIH Device Record Key: 8ce2df38-7bfb-4d12-a8c8-9488c02a9db9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: yonker
• Version Model Number: YK-81
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06921745200026 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161938

FDA Product Code

• DQA: Oximeter

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
• 06921745205014: YK-BPA1
• 06921745201061: The fingertip pulse oximeter can be used to measure human haemoglobin saturation and pulse rate