FDA.reportPublic FDA data

Aria Free™

Primary DI
00860003034743
Brand
Aria Free™
Company
Inova Labs, Inc.
Model
R0005
Catalog number
R0005
Device description
Companion Bag - Standard
Published
2021-03-24
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
00860003034743PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003034743008600030347438600030347430860003034743

GMDN Terms#

Term, Definition table
TermDefinition
Medical bagA portable, durable, hand-held container of plastic, fabric, or leather designed for transportation of small medical devices, instruments, and/or supplies. It typically includes attachments for easy handling and mechanisms for closure and/or locking; it may have the internal space appropriately configured according to the intended contents (e.g., stethoscopes, sphygmomanometers, drugs). It may be dedicated for a variety of purposes and/or users, including specialization for physicians, nurses, first aid providers, or paramedics. This is a reusable device.

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860003034750Aria Free™R0006R00062021-01-15
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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00850078826282BioTAB LLCBiotab LLCJOW2026-10-26
00850078826299BioTAB LLCBiotab LLCJOW2026-10-26
00850078826305BioTAB LLCBiotab LLCJOW2026-10-26
00850078826312BioTAB LLCBiotab LLCJOW2026-10-26
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50885380194632KendallCardinal Health 200, LLCJOW2026-07-31
50885380194649KendallCardinal Health 200, LLCJOW2026-07-31
50885380194656KendallCardinal Health 200, LLCJOW2026-07-31
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