Non-adhesive Disposable sensor with Velcro Tape -

GUDID CST05027042

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: CST05027042
• NIH Device Record Key: 9727de5f-e0a2-47ae-8cf9-4b95a3f5228f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Non-adhesive Disposable sensor with Velcro Tape -
• Version Model Number: CST050-2704
• 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	B425CST05027042 [Primary]
HIBCC	CST05027042 [Package]; Contains: B425CST05027042; 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: 2016-12-01

On-Brand Devices [Non-adhesive Disposable sensor with Velcro Tape - ]

• CST05029642: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST05029542: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST05029042: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST05027042: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST05026042: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST05024042: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST05023042: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont
• CST05021242: SpO2 sensors are electro-optical sensors that function without skin penetration, electrical cont