S3A 150100

GUDID B9671501000

Oxygen Analyzer

Aei Technologies, Inc.

Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor Respiratory oxygen sensor

• Primary Device ID: B9671501000
• NIH Device Record Key: 4219ab62-7a2a-45a7-acbc-afd2a8cfd8b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: S3A
• Version Model Number: S3A
• Catalog Number: 150100
• Company DUNS: 961851326
• Company Name: Aei Technologies, Inc.
• 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: false
• 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: false

Customer Support Contacts

• Phone: +1-630-548-3545
• Email: info@aeitechnologies.com
• Phone: +1-630-548-3545
• Email: info@aeitechnologies.com
• Phone: +1-630-548-3545
• Email: info@aeitechnologies.com
• Phone: +1-630-548-3545
• Email: info@aeitechnologies.com
• Phone: +1-630-548-3545
• Email: info@aeitechnologies.com
• Phone: +1-630-548-3545
• Email: info@aeitechnologies.com
• Phone: +1-630-548-3545
• Email: info@aeitechnologies.com
• Phone: +1-630-548-3545
• Email: info@aeitechnologies.com
• Phone: +1-630-548-3545
• Email: info@aeitechnologies.com
• Phone: +1-630-548-3545
• Email: info@aeitechnologies.com
• Phone: +1-630-548-3545
• Email: info@aeitechnologies.com
• Phone: +1-630-548-3545
• Email: info@aeitechnologies.com
• Phone: +1-630-548-3545
• Email: info@aeitechnologies.com
• Phone: +1-630-548-3545
• Email: info@aeitechnologies.com
• Phone: +1-630-548-3545
• Email: info@aeitechnologies.com
• Phone: +1-630-548-3545
• Email: info@aeitechnologies.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B9671501000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K943824

FDA Product Code

• CCL: Analyzer, Gas, Oxygen, Gaseous-Phase

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: 2021-11-11
• Device Publish Date: 2021-11-03

Devices Manufactured by Aei Technologies, Inc.

• B9671501000 - S3A: 2021-11-11Oxygen Analyzer
• B9671501000 - S3A: 2021-11-11 Oxygen Analyzer
• B9671502000 - CD3A: 2021-11-11 Carbon Dioxide Analyzer
• B9671503000 - MOXUS: 2021-11-11 Metabolic Measurement System
• B9671504000 - MAXII: 2021-11-11 Metabolic Measurement System