FDA.reportPublic FDA data

Airwear Air Compression Wrap

Primary DI
00816305023626
Brand
Airwear Air Compression Wrap
Company
Tactile Systems Technology, Inc.
Model
AW-XL-01-BK
Device description
Compression Wrap, Single Box Pack-Out, Extra Large, Airwear
Published
2019-10-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
MHWDressing, Compression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MHWDressing, CompressionGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816305023626PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816305023626008163050236268163050236260816305023626

GMDN Terms#

Term, Definition table
TermDefinition
Compression/pressure sock/stocking, reusableA garment in the form of a sock or stocking intended to fit tightly over the leg and foot to apply compression/pressure (i.e., graduated or even-force), typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)]. It is not a strip/roll binder or tubular support bandage, and is not designed to cover the pelvis. It is typically made of elastic material (e.g., circular knit nylon/Spandex yarns) and may be referred to as a flight sock; it does not include antimicrobial features. It is normally available [non-prescription] over-the-counter (OTC) for use in the home and/or for hospitalized patients. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
146295980
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816305024890AffloVest6100XS2026-05-27
00816305024906AffloVest6200S2026-05-27
00816305024913AffloVest6300M2026-05-27
00816305024920AffloVest6400L2026-05-27
00816305024937AffloVest6500XL2026-05-27
00816305025101AffloVest704268-001704268-0012026-05-27
00816305025248AffloVestWR6100XS2026-05-27
00816305025255AffloVestWR6200S2026-05-27
00816305025262AffloVestWR6300M2026-05-27
00816305025279AffloVestWR6400L2026-05-27
00816305025286AffloVestWR6500XL2026-05-27
00816305025088FlexiTouch Plus704705-001N/A2025-08-11
00816305025095Nimbl703439-001N/A2025-08-11
00816305025064FlexiTouch Plus702610-0012025-07-17
00816305025071NimblDS PL-HL-00-LR2025-07-17
00816305023596Airwear Air Compression WrapAW-SM-01-BK2019-10-18
00816305023602Airwear Air Compression WrapAW-MD-01-BK2019-10-18
00816305023619Airwear Air Compression WrapAW-LG-01-BK2019-10-18
00816305023633Airwear Air Compression WrapAW-SO-01-WH2019-10-18
00816305023640Airwear Air Compression WrapAW-PU-01-GR2019-10-18

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