FDA.reportPublic FDA data

AIROS

Primary DI
00850031012769
Brand
AIROS
Company
AIROS MEDICAL INC
Model
ACGE
Device description
Arterial Compression Garment Expander
Published
2026-10-09
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOWSleeve, Limb, Compressible

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850031012766PackageGS1250In Commercial Distribution
00850031012769PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003101276610850031012766
00850031012769008500310127698500310127690850031012769

GMDN Terms#

Term, Definition table
TermDefinition
Intermittent 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 intermittently applying pressure to a patient's arms or legs to promote venous blood flow at timed intervals. This is achieved through the cyclical inflation and deflation of a single-chambered stocking, sleeve, or suit applied to the extremities. The system typically consists of a compression pump, control and timing mechanism, tubing, and pneumatic stocking(s) or suit.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
866-991-6956dbehuniak@airosmedical.com

Regulatory Flags#

DUNS number
080942280
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850031012622AIROS8-SPXXL022026-01-23
00850031012639AIROS8-MPXL022026-01-23
00850031012646AIROS8-MPXXL022026-01-23
00850031012653AIROS8-LPXL022026-01-23
00850031012660AIROS8-LPXXL022026-01-23
00850031012615AIROS8-SPXL022026-01-23
10850031012629AIROS8-SPXXL022026-01-23
10850031012636AIROS8-MPXL022026-01-23
10850031012643AIROS8-MPXXL022026-01-23
10850031012650AIROS8-LPXL022026-01-23
10850031012667AIROS8-LPXXL022026-01-23
00855682007409AIROSAACD032026-01-23
00850031012608AIROSACG022025-04-17
10850031012605AIROSACG022025-04-17
00855682007386AIROSACG012024-10-15
00855682007379AIROSAACD012024-10-15
10855682007383AIROSACG012024-10-15
00850031012004AIROSA600P2023-01-18
00850031012011AIROSA800P2023-01-18
00850031012530AIROSA600A2023-01-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812311022448Sequential CirculatorBio Compression Systems, IncJOW2026-09-29
00812311022486Sequential CirculatorBio Compression Systems, IncJOW2026-09-29
00190446979128AIRCASTDJO, LLCJOW2026-08-03
50885380194564KendallCardinal Health 200, LLCJOW2026-07-31
50885380194571KendallCardinal Health 200, LLCJOW2026-07-31
50885380194588KendallCardinal Health 200, LLCJOW2026-07-31
50885380194601KendallCardinal Health 200, LLCJOW2026-07-31
50885380194618KendallCardinal Health 200, LLCJOW2026-07-31
50885380194625KendallCardinal Health 200, LLCJOW2026-07-31
50885380194632KendallCardinal Health 200, LLCJOW2026-07-31
50885380194649KendallCardinal Health 200, LLCJOW2026-07-31
50885380194656KendallCardinal Health 200, LLCJOW2026-07-31
50885380194663KendallCardinal Health 200, LLCJOW2026-07-31
50885380194670KendallCardinal Health 200, LLCJOW2026-07-31
50885380194694KendallCardinal Health 200, LLCJOW2026-07-31
10888277348226MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-29
10193489024517MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-22
10888277348141MEDLINEMEDLINE INDUSTRIES, INC.JOW2026-07-22
96973521878410BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
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96973521878496BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878502BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878519BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22
96973521878526BlissCuffShenzhen Vistar Medical Supplies Co.,Ltd.JOW2026-07-22