AeroForm® Tissue Expander BR125-400

GUDID 10851452007010

AIRXPANDERS INC

Remotely-controlled tissue expander

• Primary Device ID: 10851452007010
• NIH Device Record Key: 0dc8af7a-35f3-4ccf-8f50-5eb5236f7904
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AeroForm® Tissue Expander
• Version Model Number: 400cc Small
• Catalog Number: BR125-400
• Company DUNS: 860020127
• Company Name: AIRXPANDERS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)349-2479
• Email: uscustomerservice@airXpander.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10851452007010 [Primary]

FDA Product Code

• PQN: Carbon dioxide gas controlled tissue expander

Sterilization

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

[10851452007010]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-09-23
• Device Publish Date: 2017-06-21

On-Brand Devices [AeroForm® Tissue Expander]

• 10851452007034: 800cc Large
• 10851452007027: 600cc Medium
• 10851452007010: 400cc Small