Caremed SA30Y-15R

GUDID 06970758507691

Caremed SpO2 sensor

Shenzhen Caremed Medical Technology Co., Ltd.

Pulse oximeter probe, reusable

• Primary Device ID: 06970758507691
• NIH Device Record Key: 5aa7ceec-c637-417d-8c97-7cbe9f1f9372
• Commercial Distribution Discontinuation: 2019-10-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Caremed
• Version Model Number: SA30Y-15R
• Catalog Number: SA30Y-15R
• Company DUNS: 544335718
• Company Name: Shenzhen Caremed Medical 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970758507691 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153184

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: 2019-11-07
• Device Publish Date: 2019-10-30

On-Brand Devices [Caremed]

• 06970758500173: Caremed Disposable SpO2 Sensors
• 06970758500166: Caremed Reusable SpO2 Sensors
• 06970758500159: Caremed Reusable SpO2 Sensors
• 06970758500142: Caremed Patient Cable and Leadwires
• 06970758500135: Caremed Patient Cable and Leadwires
• 06970758500128: Caremed Patient Cable and Leadwires
• 06970758500111: Caremed Patient Cable and Leadwires
• 06970758500104: Caremed Patient Cable and Leadwires
• 06970758500098: Caremed Patient Cable and Leadwires
• 06970758500029: Caremed Reusable SpO2 Sensors
• 06970758500012: Caremed Patient Cable and Leadwires
• 06970758507691: Caremed SpO2 sensor
• 06970758507615: Caremed ECG lead wire
• 06970758507677: Caremed ECG lead wire
• 06970758507820: Caremed NIBP CUFFS AND ACCESSORIES
• 06970758507806: Caremed NIBP Cuff
• 06970758507721: Caremed Temperature probe
• 06970758507707: Caremed SpO2 sensor
• 06970758507646: Caremed ECG lead wire
• 06970758507639: Caremed ECG lead wire
• 06970758507622: Caremed ECG lead wire
• 06970758507608: Caremed ECG lead wire