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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719893351026WellellWellell Inc.JOW2026-03-17
00812311022363BIOARTERIAL+Bio Compression Systems, IncJOW2026-03-09
00850033615272ThermoTek WRAP, DVT, CALF SET, PUSH, SPUTHERMOTEK, INC.JOW2026-02-21
00850033615494ThermoTek WRAP,DVT,CA,SET,PUSH,SPU, QTY 10, CTNTHERMOTEK, INC.JOW2026-02-21
00812311022479Bio Arterial DeluxeBio Compression Systems, IncJOW2026-02-13
00850001096386Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096393Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096409Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096416Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096423Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096430Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096447Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096461Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096478Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096485Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096492Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096508Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096522Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096539Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096546Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
00850001096553Therm-XZENITH TECHNICAL INNOVATIONS, LLCJOW2026-02-13
10885380185120KendallCardinal Health 200, LLCJOW2026-02-10
18809802648491DVT-SERIESDAESUNG MAREF CO.,LTD.JOW2026-02-09
18809802648507DVT-SERIESDAESUNG MAREF CO.,LTD.JOW2026-02-09
10816317024427Kendall DVT SleeveRENU MEDICAL, INCJOW2026-01-27
10816317024434Kendall DVT SleeveRENU MEDICAL, INCJOW2026-01-27
10816317024441Kendall DVT SleeveRENU MEDICAL, INCJOW2026-01-27
00850031012615AIROSAIROS MEDICAL INCJOW2026-01-23
10850031012629AIROSAIROS MEDICAL INCJOW2026-01-23
10850031012636AIROSAIROS MEDICAL INCJOW2026-01-23