Pro Comfort Pulse Oximeter

GUDID 10850632007536

Non- Invasive measurement of arterial blood oxygen saturation and pulse rate.

HOME AIDE DIAGNOSTICS, INC.

Pulse oximeter, battery-powered Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter Pulse oximeter

• Primary Device ID: 10850632007536
• NIH Device Record Key: e882a83c-a427-4a0c-89f4-ed3257b3b00b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pro Comfort Pulse Oximeter
• Version Model Number: C101B1
• Company DUNS: 783518983
• Company Name: HOME AIDE DIAGNOSTICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-915-0116
• Email: info@homeaide.us
• Phone: 1-800-915-0116
• Email: info@homeaide.us
• Phone: 1-800-915-0116
• Email: info@homeaide.us
• Phone: 1-800-915-0116
• Email: info@homeaide.us
• Phone: 1-800-915-0116
• Email: info@homeaide.us
• Phone: 1-800-915-0116
• Email: info@homeaide.us
• Phone: 1-800-915-0116
• Email: info@homeaide.us
• Phone: 1-800-915-0116
• Email: info@homeaide.us
• Phone: 1-800-915-0116
• Email: info@homeaide.us
• Phone: 1-800-915-0116
• Email: info@homeaide.us
• Phone: 1-800-915-0116
• Email: info@homeaide.us
• Phone: 1-800-915-0116
• Email: info@homeaide.us
• Phone: 1-800-915-0116
• Email: info@homeaide.us
• Phone: 1-800-915-0116
• Email: info@homeaide.us
• Phone: 1-800-915-0116
• Email: info@homeaide.us
• Phone: 1-800-915-0116
• Email: info@homeaide.us

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850632007539 [Primary]
GS1	10850632007536 [Package]; Contains: 00850632007539; Package: Carton [200 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173123

FDA Product Code

• DQA: Oximeter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-23
• Device Publish Date: 2020-03-13

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