Reusable Sensor - Y

GUDID CST07031042

SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. The sensor uses optical means t

MEDIAID INC

Pulse oximeter, line-powered

• Primary Device ID: CST07031042
• NIH Device Record Key: 07d0dac6-4981-4b11-9f20-6f7f7c861aed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reusable Sensor - Y
• Version Model Number: CST070-3104
• Company DUNS: 134990550
• Company Name: MEDIAID INC
• Device Count: 1
• DM Exempt: true
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B425CST07031042 [Primary]
HIBCC	CST07031042 [Package]; Contains: B425CST07031042; Package: Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041964

FDA Product Code

• DQA: Oximeter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-06

On-Brand Devices [Reusable Sensor - Y]

• CST070316292: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• B425CST07031622: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST070313092: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST07031302: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST070312692: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST07031262: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST070312592: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST07031252: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST070312092: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST07031202: pulse Oximeter, with an optional adapter cable for compatible models.SpO2 sensors are electro-op
• CST070310792: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST07031072: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST070310692: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST07031062: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST070310492: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST07031042: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont