Adhesive Disposable SpO2 Sensors with Medaplast Ta

GUDID CST03429532

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: CST03429532
• NIH Device Record Key: b691b47d-4043-4d3a-a3c1-05d13d2f77ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adhesive Disposable SpO2 Sensors with Medaplast Ta
• Version Model Number: CST034-2953
• 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: true
• Lot Batch: true
• Serial Number: false
• 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	B425CST03429532 [Primary]
HIBCC	CST03429532 [Package]; Contains: B425CST03429532; Package: Box [24 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: 2016-11-24

On-Brand Devices [Adhesive Disposable SpO2 Sensors with Medaplast Ta]

• CST03429642: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST03429632: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST03429622: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST03429612: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST03429542: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST03429532: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST03429522: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST03429512: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST03429042: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST03429032: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST03429022: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST03429012: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST03427042: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST03427032: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST03427022: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST03427012: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST03426042: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST03426032: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST03426022: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST03426012: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST03424042: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST03424032: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST03424022: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST03424012: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST03423042: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST03423032: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST03423022: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST03423012: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST03421542: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST03421532: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST03421522: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST03421512: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST03421242: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST03421232: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST03421222: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST03421212: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont