AeroForm® Dosage Controller

Primary DI
10851452007157
Brand
AeroForm® Dosage Controller
Company
AIRXPANDERS INC
Model
V1.5
Catalog number
AF-DC-1
Published
2017-06-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PQNCarbon dioxide gas controlled tissue expander

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PQNCarbon Dioxide Gas Controlled Tissue ExpanderGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851452007157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085145200715710851452007157

GMDN Terms#

Term, Definition table
TermDefinition
Remotely-controlled tissue expander remote controlA battery-powered device designed to remotely control expansion of an implanted inflatable tissue expander and intended to be operated intermittently by the patient or physician over a prescribed period to develop tissue coverage prior to the placement of a permanent breast implant. The operator sends a coded instruction by telemetry to release a controlled volume of gas contained in a cylinder within the implant to cause the expansion. It is typically paired with the implant, which contains a programmable identification (ID) chip, in the operating room during implantation. This is a reusable device intended for single-patient use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(877)349-2479uscustomerservice@airXpander.com

Regulatory Flags#

DUNS number
860020127
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10851452007010AeroForm® Tissue Expander400cc SmallBR125-4002017-06-21
10851452007027AeroForm® Tissue Expander600cc MediumBR140-6002017-06-21
10851452007034AeroForm® Tissue Expander800cc LargeBR155-8002017-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10851452007010AeroForm® Tissue ExpanderAIRXPANDERS INCPQN2017-06-21
10851452007027AeroForm® Tissue ExpanderAIRXPANDERS INCPQN2017-06-21
10851452007034AeroForm® Tissue ExpanderAIRXPANDERS INCPQN2017-06-21