FDA.reportPublic FDA data

AeroWrap Thigh Medium Large Right

Primary DI
00856525007327
Brand
AeroWrap Thigh Medium Large Right
Company
SUN SCIENTIFIC, INC.
Model
TW6250-03
Catalog number
TWMLR
Device description
The AeroWrap Thigh™ system is intended to provide compression to the great saphenous vein on the thigh after closure to occlude the vein after surgery. The wrap consists of a inflatable portion that covers the inner thigh and additional material along with areas for securing the wrap to the thigh. The wrap also has loops for a belt to maintain the proper location. The placement of the wrap and sv bolster will help to aid in the closure of Various veins with Sclerotherapy including EVLT, RFMD, for compression of the great saphenous vein.
Published
2022-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Contact Domains#

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
00856525007327PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856525007327008565250073278565250073270856525007327

GMDN Terms#

Term, Definition table
TermDefinition
Compression/pressure tubular garmentA device in the form of a tube intended to tightly fit over and apply compression/pressure (i.e., graduated or even-force) to a part of a limb, typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)], to control scarring, and/or to manage lymphoedema; it is neither a strip/roll binder, glove, sock/stocking, nor tubular support bandage. It is typically made of cotton or synthetic elastic material (e.g., Lycra and Spandex); it does not include antimicrobial features. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
914.479-5108aalward@sun-scientific.com

Regulatory Flags#

DUNS number
609397224
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856525007082SunGauze, Gauze Dialysis Needle Dressing 60mm x 74mmPA1050-00SGP2021-07-21
00856525007068SunWrap Forearm U Bladder RightSW6280-00SW-FAUBR2021-05-10
00856525007235Rav Positioner Small2030SRAVP1000S2022-01-12
00856525007730Rav Positioner2030RAVP10002019-12-20
00856525007860Hip Off-Loader Assy, Medium FP7265 FP72652022-11-18
00856525007877Heel Off-Loader Assy, Medium HP7265 HP72652022-11-18
00856525007884SACRAL Off-Loader Assy, Medium SP7265 SP72652022-11-18
00856525007136SV BOLSTER MediumSP2355 SP23552022-04-26
00856525007143SV BOLSTER LARGESP2555 SP25552022-04-26
00856525007365PFAB SMALLPFAB-SPFAB-S2021-04-30
00856525007372PFAB MediumPFAB-MPFAB-M2021-04-30
00856525007389PFAB Medium CrescentPFAB-MCPFAB-MC2021-04-30
00856525007396PFAB LargePFAB-LPFAB-L2021-04-30
00850051939565AeroWrap™ Full LegFL-FL-SL-L-SF-SFL-FL-SL-L-SF-S2024-12-05
00850051939572AeroWrap™ Full LegFL-FL-SL-L-SF-MFL-FL-SL-L-SF-M2024-12-05
00850051939589AeroWrap™ Full LegFL-FL-SL-L-SF-LFL-FL-SL-L-SF-L2024-12-05
00850051939596AeroWrap™ Full LegFL-FL-SL-L-MF-SFL-FL-SL-L-MF-S2024-12-05
00850051939602AeroWrap™ Full LegFL-FL-SL-L-MF-MFL-FL-SL-L-MF-M2024-12-05
00850051939619AeroWrap™ Full LegFL-FL-SL-L-MF-LFL-FL-SL-L-MF-L2024-12-05
00850051939626AeroWrap™ Full LegFL-FL-SL-L-LF-SFL-FL-SL-L-LF-S2024-12-05

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M68931150030TQ™ RAMSafeguard US Operating, LLCMHW2025-01-29
10884450828745SAFEGUARD FOCUS™Merit Medical Systems, Inc.MHW2025-01-01
10193489084658MEDLINEMEDLINE INDUSTRIES, INC.MHW2024-09-13
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00810041983619ViveVIVE HEALTH LLCMHW2024-06-07
00810041982087ViveVIVE HEALTH LLCMHW2024-06-05
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00840117327849"Sensi Wrap,Self-Adherent - Latex Free 2 x 5"" yds Light Blue"Dynarex CorporationMHW2023-12-20
00840117327863"Sensi Wrap,Self-Adherent - Latex Free 2"" x 5 yds Purple "Dynarex CorporationMHW2023-12-20
00840117327887"Sensi Wrap,Self-Adherent - Latex Free 2"" x 5 yd Pink"Dynarex CorporationMHW2023-12-20
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00840117327924"Sensi Wrap,Self-Adherent - Latex Free 3"" x 5 yds Green"Dynarex CorporationMHW2023-12-20
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00840117327740"Sensi Wrap,Self-Adherent - Latex Free 1"" x 5 yds Blue"Dynarex CorporationMHW2023-12-17
00840117327764"Sensi Wrap,Self-Adherent - Latex Free 1"" x 5 yds Purple "Dynarex CorporationMHW2023-12-17
00840117327788"Sensi Wrap,Self-Adherent - Latex Free 1"" x 5 yds Pink"Dynarex CorporationMHW2023-12-17
00840117327801"Sensi Wrap,Self-Adherent - Latex Free 2"" x 5 yd Red "Dynarex CorporationMHW2023-12-17
10811331010173Comfort BandTz Medical, Inc.MHW2023-10-20
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00810113571959ViveVIVE HEALTH LLCMHW2023-08-07
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00810113571973ViveVIVE HEALTH LLCMHW2023-08-07