AeroForm® Tissue Expander

Basic Information

• Brand Name: AeroForm® Tissue Expander
• Primary DI: 10851452007034
• Version / Model: 800cc Large
• Catalog Number: BR155-800
• Company Name: AIRXPANDERS INC
• Labeler DUNS: 860020127
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-21
• Public Version: 3
• Public Version Date: 2019-09-23
• Public Version Status: Update
• Public Device Record Key: 81d08ddd-91bd-4ce2-85ed-a8f2a18e0ff8

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PQN	Carbon dioxide gas controlled tissue expander	General, Plastic Surgery	878.3510	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59370	Remotely-controlled tissue expander	A device intended for implantation to develop tissue (skin) coverage by intermittent expansion, which can be remotely controlled by the patient or physician, prior to the placement of a permanent breast implant. Expansion is achieved by electronic release of gas [e.g., carbon dioxide (CO2)] from a pressurized container within the device. It typically consists of an outer silicone shell, an inner gas barrier, a reservoir of gas with valve, and electronics. It is intended to remain in situ until desired expansion is achieved, when it is replaced with the breast implant. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10851452007034	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Large, 800cc
Total Volume	800	Milliliter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius