FDA.reportPublic FDA data

AeroWrap Extension Panel small/medium

Primary DI
00850051939282
Brand
AeroWrap Extension Panel small/medium
Company
SUN SCIENTIFIC, INC.
Model
VU6154
Catalog number
AW-EXT-SB
Device description
An extension panel for oversized legs that aids in the extension of the AeroWrap which wraps around the leg and provides compression. The device is intended for use in the home or a clinical setting for oversized legs. This is a single-use device.
Published
2024-01-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
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
00850051939282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850051939282008500519392828500519392820850051939282

GMDN Terms#

Term, Definition table
TermDefinition
Sequential 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 applying sequential pressure to a patient's legs to promote venous blood flow. It consists of a compression pump, control/timing mechanism, tubing and has pneumatic stockings, sleeves, or a suit with several chambers that inflate and deflate sequentially in a pattern beginning at the foot or ankle and continuing to chambers around the calf and thigh. In some systems, each chamber reaches the same pressure but at different times, while others apply greater pressure distally which gradually diminishes higher up.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9144795108aalward@sun-scientific.com

Regulatory Flags#

DUNS number
609397224
Device count
1
Premarket exempt
true
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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