MACS 20201

GUDID 00853678006030

MACS CPAP System

AIRON CORPORATION

In-line CPAP set, nebulizing

• Primary Device ID: 00853678006030
• NIH Device Record Key: 007479be-0113-4f8d-bc61-221d9f300211
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MACS
• Version Model Number: MACS CPAP System
• Catalog Number: 20201
• Company DUNS: 015222912
• Company Name: AIRON CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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: 321-821-9433
• Email: info@aironusa.com

Device Dimensions

• Height: 6.7 Inch
• Height: 6.7 Inch
• Height: 6.7 Inch
• Height: 6.7 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between -51 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Storage Environment Temperature: Between -51 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Storage Environment Temperature: Between -51 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Storage Environment Temperature: Between -51 Degrees Fahrenheit and 160 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853678006030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080692

FDA Product Code

• BTL: Ventilator, Emergency, Powered (Resuscitator)

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: 2015-10-23

On-Brand Devices [MACS]

• 00853678006665: Adult / pediatric CPAP patient circuit, disposable, single patient use 6 feet long, with large m
• 00853678006085: Adult / pediatric CPAP patient circuit, disposable, single patient use 6 feet long with large ma
• 00853678006047: MACS epic CPAP System
• 00853678006030: MACS CPAP System