Reusable Sensor - Ear

GUDID CST06431302

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: CST06431302
• NIH Device Record Key: dc8f46c0-b440-4d29-9104-2e84f1ed651f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reusable Sensor - Ear
• Version Model Number: CST064-3130
• 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: true
• 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	B425CST06431302 [Primary]
HIBCC	CST06431302 [Package]; Contains: B425CST06431302; 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 - Ear]

• CST064316292: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST06431622: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST064313092: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST06431302: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST064312692: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST06431262: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST064312592: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST06431252: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST064312092: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST06431202: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST064310792: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST06431072: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST064310692: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST06431062: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST064310492: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST06431042: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont