Adhesive Disposable SpO2 Sensors with Micro Foam T

GUDID CST02024022

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: CST02024022
• NIH Device Record Key: 2808e307-1ed3-40ed-910d-561325f8ceb6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adhesive Disposable SpO2 Sensors with Micro Foam T
• Version Model Number: CST020-2402
• 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	B425CST02024022 [Primary]
HIBCC	CST02024022 [Package]; Contains: B425CST02024022; 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: 2016-11-25

On-Brand Devices [Adhesive Disposable SpO2 Sensors with Micro Foam T]

• CST02029642: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST02029632: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST02029622: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST02029612: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST02029542: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST02029532: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST02029522: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST02029512: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST02029042: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST02029032: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST02029022: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST02029012: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST02027042: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST02027032: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST02027022: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• B425CST02027012: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST02026042: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST02026032: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST02026022: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST02026012: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST02024042: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST02024032: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST02024022: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST02024012: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST02023042: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST02023032: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST02023022: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• B425CST02023012: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST02022042: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST02022032: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST02022022: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST02022012: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST02021242: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST02021232: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST02021222: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST02021212: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont