FDA.reportPublic FDA data

Aria Free™

Primary DI
00860003034750
Brand
Aria Free™
Company
Inova Labs, Inc.
Model
R0006
Catalog number
R0006
Device description
Aria Free, connector tube
Published
2021-01-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOWSleeve, Limb, Compressible

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOWSleeve, Limb, CompressibleCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200564000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200564000Aria SystemInova Labs2020-04-03JOW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003034750PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003034750008600030347508600030347500860003034750

GMDN Terms#

Term, Definition table
TermDefinition
Sequential venous compression systemA system used for the noninvasive treatment and prevention of venous disorders and sequelae such as oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE). It functions by applying sequential pressure to a patient's legs to promote venous blood flow. It consists of a compression pump, control/timing mechanism, tubing and has pneumatic stockings, sleeves, or a suit with several chambers that inflate and deflate sequentially in a pattern beginning at the foot or ankle and continuing to chambers around the calf and thigh. In some systems, each chamber reaches the same pressure but at different times, while others apply greater pressure distally which gradually diminishes higher up.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(866) 647 0691support@aria-therapy.com

Regulatory Flags#

DUNS number
016523183
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860003034743Aria Free™R0005R00052021-03-24
00860003034712Aria Free™R0002R00022020-10-27
00860003034729Aria Free™R0003R00032020-10-27
00860003034736Aria Free™R0004R00042020-10-27
08582530040012Lifechoice Activox P4L XYC100B-P4LAOX-P4L-US2016-08-17
08582530040029Lifechoice Activox P4LXYC100B-P4LAOX-P4L-US(U)2016-08-17
08582530040036Lifechoice Activox P4LXYC100B-P4LAOX-P4L-US(U)-B2016-08-17
08582530040043Lifechoice Activox P4LXYC100B-P4LAOX-P4L-US-B2016-08-17
08582530041149MOBI AMER135001350012018-04-26

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Primary DI, Brand, Company table
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