konsung

GUDID 06934822531296

This device is a small, lightweight, portable device intended for use in measuring and displaying oxygen saturation of functional arterial haemoglobin (%SpO2) and pulse rate (PR).The device measures SpO2 and PR with a SpO2 senror and displays on the OLED after certain further processing. The device is mainly composed of the motherboard, SpO2 transducer and built-in battery. The power supply is 4.2V Li-battery and also the subject device can be powered by adapter. The subject device has a detachable sensor as an accessory to measure the SpO2 and pulse rate (PR). The subject device is not for life-supporting or life-sustaining and it is not an implantable device. The subject device owns software which has been validated by the manufacturer.

Jiangsu Konsung Bio Medical Science and Technology Co., Ltd.

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 Pulse oximeter Pulse oximeter

• Primary Device ID: 06934822531296
• NIH Device Record Key: 65e2b198-0928-4302-909a-665e631ae90b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: konsung
• Version Model Number: SONOSAT-W01T
• Company DUNS: 544307339
• Company Name: Jiangsu Konsung Bio Medical Science and 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06934822531296 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152089

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: 2023-07-10
• Device Publish Date: 2023-06-30

On-Brand Devices [konsung]

• 06934822531296: This device is a small, lightweight, portable device intended for use in measuring and displayin
• 06934822531234: This device is a small, lightweight, portable device intended for use in measuring and displayin
• 06934822531173: This device is a small, lightweight, portable device intended for use in measuring and displayin
• 06934822565031: The Oxygen Concentrator is intended to be used by patients with respiratory disorders who requir
• 06934822565024: The Oxygen Concentrator is intended to be used by patients with respiratory disorders who requir
• 06934822565017: The Oxygen Concentrator is intended to be used by patients with respiratory disorders who requir