MTS OX400A

GUDID 00869667000415

The OX-400A Finger Pulse Oximeter will display oxygen saturation (Spo2) and pulse rate (PR) automatically. It also displays the perfusion index (PI) to help in selecting the best site for testing, providing fast and accurate oximetry measurements.

MEDICAL TEST SUPPLY

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: 00869667000415
• NIH Device Record Key: 78d978a6-ee8d-4084-a7f2-9703976ded75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MTS
• Version Model Number: OX-400A
• Catalog Number: OX400A
• Company DUNS: 064063916
• Company Name: MEDICAL TEST SUPPLY
• Device Count: 1
• DM Exempt: false
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-855-270-5357
• Email: customerservice@medicaltestsupply.com
• Phone: 1-855-270-5357
• Email: customerservice@medicaltestsupply.com
• Phone: 1-855-270-5357
• Email: customerservice@medicaltestsupply.com
• Phone: 1-855-270-5357
• Email: customerservice@medicaltestsupply.com
• Phone: 1-855-270-5357
• Email: customerservice@medicaltestsupply.com
• Phone: 1-855-270-5357
• Email: customerservice@medicaltestsupply.com
• Phone: 1-855-270-5357
• Email: customerservice@medicaltestsupply.com
• Phone: 1-855-270-5357
• Email: customerservice@medicaltestsupply.com
• Phone: 1-855-270-5357
• Email: customerservice@medicaltestsupply.com
• Phone: 1-855-270-5357
• Email: customerservice@medicaltestsupply.com
• Phone: 1-855-270-5357
• Email: customerservice@medicaltestsupply.com
• Phone: 1-855-270-5357
• Email: customerservice@medicaltestsupply.com
• Phone: 1-855-270-5357
• Email: customerservice@medicaltestsupply.com
• Phone: 1-855-270-5357
• Email: customerservice@medicaltestsupply.com
• Phone: 1-855-270-5357
• Email: customerservice@medicaltestsupply.com
• Phone: 1-855-270-5357
• Email: customerservice@medicaltestsupply.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869667000415 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063641

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: 2017-11-09

On-Brand Devices [MTS]

• 00869667000453: The OX-500A Finger Pulse Oximeter will display oxygen saturation (Spo2) and pulse rate (PR) auto
• 00869667000446: The OX-550AP Pediatric Finger Pulse Oximeter will display oxygen saturation (Spo2) and pulse rat
• 00869667000439: The OX-200A Finger Pulse Oximeter will display oxygen saturation (Spo2) and pulse rate (PR) auto
• 00869667000422: The OX-300A Finger Pulse Oximeter will display oxygen saturation (Spo2) and pulse rate (PR) auto
• 00869667000415: The OX-400A Finger Pulse Oximeter will display oxygen saturation (Spo2) and pulse rate (PR) auto
• 00869667000408: The OX-610A Wrist Pulse Oximeter is fully automatic. It displays and records oxygen saturation (