FDA.report

Airwear Air Compression Wrap

Primary DI
00816305023596
Brand
Airwear Air Compression Wrap
Company
TACTILE SYSTEMS TECHNOLOGY, INC.
Model
AW-SM-01-BK
Device description
Compression Wrap, Single Box Pack-Out, Small, Airwear
Published
2019-10-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
MHWDressing, Compression

Product Code Classifications

CodeDeviceSpecialtyClass
MHWDressing, CompressionGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816305023596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816305023596008163050235968163050235960816305023596

GMDN Terms

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

Regulatory Flags

DUNS number
146295980
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
true
Sterilization required before use
false

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