Reusable Sensor - Compushield (SCS)

GUDID POX050400S2

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: POX050400S2
• NIH Device Record Key: 022c6039-ac4d-4159-833e-e17abc5604f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reusable Sensor - Compushield (SCS)
• Version Model Number: POX050-400S
• 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	B425POX050400S2 [Primary]
HIBCC	POX050400S2 [Package]; Contains: B425POX050400S2; 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: 2016-12-08

On-Brand Devices [Reusable Sensor - Compushield (SCS)]

• POX050531S2: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• POX050400S2: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• POX050310S2: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• POX050115S2: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• POX050105S2: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont