Foot Compression Wrap Large FCW-300

GUDID 00856525007976

Aero-Wrap™ Foot Compression Wrap is designed to provide therapeutic compression therapy, in the inpatient and outpatient setting, in the treatment of edema and lymphedema of the foot or as part of a wound treatment protocol.

SUN SCIENTIFIC, INC.

Compression/pressure sock/stocking, reusable
Primary Device ID00856525007976
NIH Device Record Key1848ec08-7800-4e06-9313-bf6fd7f31d51
Commercial Distribution Discontinuation2030-05-18
Commercial Distribution StatusIn Commercial Distribution
Brand NameFoot Compression Wrap Large
Version Model NumberMW5360
Catalog NumberFCW-300
Company DUNS609397224
Company NameSUN SCIENTIFIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Countertrue

Customer Support Contacts

Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com
Phone9144795108
Emailaalward@sun-scientific.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100856525007976 [Primary]

FDA Product Code

MHWDressing, Compression

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-20
Device Publish Date2023-11-10

Devices Manufactured by SUN SCIENTIFIC, INC.

00850051939565 - AeroWrap™ Full Leg2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k
00850051939572 - AeroWrap™ Full Leg2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k
00850051939589 - AeroWrap™ Full Leg2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k
00850051939596 - AeroWrap™ Full Leg2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k
00850051939602 - AeroWrap™ Full Leg2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k
00850051939619 - AeroWrap™ Full Leg2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k
00850051939626 - AeroWrap™ Full Leg2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k
00850051939640 - AeroWrap™ Full Leg2024-12-13 The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the k

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