Home GUDID 00850070012003
AeroWrap™ Full Leg
Primary DI 00850070012003
Brand AeroWrap™ Full Leg
Company SUN SCIENTIFIC, INC.
Model FL-FR-MLR-L-LF-L
Catalog number FL-FR-MLR-L-LF-L
Device description The AeroWrap ™ Full Leg System is comprised of inflatable gradient compression sleeves, a Brace sleeve from the ankle to the knee a Thigh sleeve from the knee to the crotch, a compression knee wrap, and a foot compression wrap. A hand pump is included to provide static compression for compression therapy. The AeroWrap™ Full Leg gradient compression system sleeves are non-sterile single patient use medical devices. An inflation source can be attached to the inflation valve on the sleeve. There is a hand pump provided as an inflation source to provide static compression. The systems are intended for hospital and outpatient use..
Published 2024-12-05
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
Product Codes# Code, Name table Code Name MHW Dressing, Compression
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MHW Dressing, Compression General Hospital 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850070012003 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850070012003 00850070012003 850070012003 0850070012003
GMDN Terms# Term, Definition table Term Definition Multi-chamber venous compression system garment, single-use A non-sterile, inflatable device in the form of a stocking, sleeve, or suit intended to be applied to the limbs externally to promote venous blood flow. As part of a compression system, the device applies pressure to the extremities through the sequential inflation of several chambers. The resulting increased venous blood flow may help to treat/prevent oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE) in non-ambulatory patients or patients at risk. This is a single-use device.
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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published M68932700080 BATTLE BANDAGE Safeguard US Operating, LLC MHW 2025-08-01 10884450828752 SAFEGUARD FOCUS COOL™ Merit Medical Systems, Inc. MHW 2025-07-01 10884450844240 SAFEGUARD FOCUS COOL™ Merit Medical Systems, Inc. MHW 2025-03-07 M68931150030 TQ™ RAM Safeguard US Operating, LLC MHW 2025-01-29 10884450828745 SAFEGUARD FOCUS™ Merit Medical Systems, Inc. MHW 2025-01-01 10193489084658 MEDLINE MEDLINE INDUSTRIES, INC. MHW 2024-09-13 00810041983572 Vive VIVE HEALTH LLC MHW 2024-06-07 00810041983589 Vive VIVE HEALTH LLC MHW 2024-06-07 00810041983596 Vive VIVE HEALTH LLC MHW 2024-06-07 00810041983602 Vive VIVE HEALTH LLC MHW 2024-06-07 00810041983619 Vive VIVE HEALTH LLC MHW 2024-06-07 00810041982087 Vive VIVE HEALTH LLC MHW 2024-06-05 00840117327825 "Sensi Wrap,Self-Adherent - Latex Free 2 x 5"" yds Green" Dynarex Corporation MHW 2023-12-20 00840117327849 "Sensi Wrap,Self-Adherent - Latex Free 2 x 5"" yds Light Blue" Dynarex Corporation MHW 2023-12-20 00840117327863 "Sensi Wrap,Self-Adherent - Latex Free 2"" x 5 yds Purple " Dynarex Corporation MHW 2023-12-20 00840117327887 "Sensi Wrap,Self-Adherent - Latex Free 2"" x 5 yd Pink" Dynarex Corporation MHW 2023-12-20 00840117327900 "Sensi Wrap,Self-Adherent - Latex Free 3"" x 5 yds Red" Dynarex Corporation MHW 2023-12-20 00840117327924 "Sensi Wrap,Self-Adherent - Latex Free 3"" x 5 yds Green" Dynarex Corporation MHW 2023-12-20 00840117327726 "Sensi Wrap,Self-Adherent - Latex Free 1"" x 5 yds Green" Dynarex Corporation MHW 2023-12-17 00840117327740 "Sensi Wrap,Self-Adherent - Latex Free 1"" x 5 yds Blue" Dynarex Corporation MHW 2023-12-17 00840117327764 "Sensi Wrap,Self-Adherent - Latex Free 1"" x 5 yds Purple " Dynarex Corporation MHW 2023-12-17 00840117327788 "Sensi Wrap,Self-Adherent - Latex Free 1"" x 5 yds Pink" Dynarex Corporation MHW 2023-12-17 00840117327801 "Sensi Wrap,Self-Adherent - Latex Free 2"" x 5 yd Red " Dynarex Corporation MHW 2023-12-17 10811331010173 Comfort Band Tz Medical, Inc. MHW 2023-10-20 10811331010180 Comfort Band Tz Medical, Inc. MHW 2023-10-20 00810113571249 Vive VIVE HEALTH LLC MHW 2023-08-07 00810113571256 Vive VIVE HEALTH LLC MHW 2023-08-07 00810113571959 Vive VIVE HEALTH LLC MHW 2023-08-07 00810113571966 Vive VIVE HEALTH LLC MHW 2023-08-07 00810113571973 Vive VIVE HEALTH LLC MHW 2023-08-07