O2-MAX

GUDID 10841470102194

ENGINEERED MEDICAL SYSTEMS INC

Respiratory oxygen therapy system

• Primary Device ID: 10841470102194
• NIH Device Record Key: 575f2081-e1db-4c66-9251-9f3f217f68c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: O2-MAX
• Version Model Number: 313-8007X
• Company DUNS: 154502934
• Company Name: ENGINEERED MEDICAL SYSTEMS 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 317-246-5505
• Email: info@pulmodyne.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841470102197 [Primary]
GS1	10841470102194 [Package]; Contains: 00841470102197; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• BYE: Attachment, Breathing, Positive End Expiratory Pressure

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-11
• Device Publish Date: 2016-01-22

Devices Manufactured by ENGINEERED MEDICAL SYSTEMS INC

• 10841470108356 - FENEM: 2023-12-20
• 10841470108370 - FENEM: 2023-12-20
• 10841470109988 - A-PEP: 2023-12-20
• 10841470111196 - DPM: 2023-12-20
• 10841470100220 - Bacterial/Viral Filter: 2023-12-19
• 00841470100230 - Pulmonary Function Filter: 2023-12-19
• 10841470100985 - Aero-Pro: 2023-12-19
• 10841470103436 - Aero-Pro: 2023-12-19