AeroWrap™ Flex Small BiLateral MSB-SF

GUDID 00856525007419

The AeroWrap ™ Flex System is comprised of a gradient compression sleeve, and hand pump to provide static compression for compression therapy or DVT Prophylaxis. The AeroWrap™ Flex gradient compression sleeve is a non-sterile single patient use medical device. The AeroWrap™ Flex Gradient Compression Sleeve contains a single bladder with a built-in gradient profile and inelastic straps to affix it to the patient’s leg from the ankle to the knee. An inflation source is attached to the inflation valve on the sleeve. There is a inflation source provided: a hand pump to provide static compression. The system is intended for hospital and outpatient use.

SUN SCIENTIFIC, INC.

Sequential venous compression system
Primary Device ID00856525007419
NIH Device Record Key0624697b-faa9-4fbe-be15-09b1c8d213c0
Commercial Distribution Discontinuation2030-10-31
Commercial Distribution StatusIn Commercial Distribution
Brand NameAeroWrap™ Flex Small BiLateral
Version Model NumberSmall Flex Bi
Catalog NumberMSB-SF
Company DUNS609397224
Company NameSUN SCIENTIFIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
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
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
GS100856525007419 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JOWSleeve, Limb, Compressible
MHWDressing, Compression

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-25
Device Publish Date2022-04-15

Devices Manufactured by SUN SCIENTIFIC, INC.

00850051939558 - Knee Compression Wrap Large2024-10-03 Aero-Wrap™ Knee Compression Wrap is designed to provide therapeutic compression therapy, in the inpatient and outpatient setti
00850051939527 - CopperUnder sock Small/Medium2024-09-18 A sock made with 40% MODAACRYLIC infused with copper polyester small/medium
00850051939534 - CopperUnder sock Large2024-09-18 A sock made with 40% MODAACRYLIC infused with copper polyester Large
00850051939541 - CopperUnder sock Extra Large2024-09-18 A sock made with 40% MODAACRYLIC infused with copper polyester Extra Large
00850051939367 - ExuCare Scalp Large2024-08-26 ExuCare Scalp is a wrap dressing designed to provide drainage absorption for the Head
00850051939374 - ExuCare Scalp Pediatric2024-08-26 ExuCare Scalp is a wrap dressing designed to provide drainage absorption for the Head
00850051939381 - ExuCare Large with foot2024-08-08 A wound cover that wraps around the leg and foot which is intended to be used as an initial, short-term treatment after injury t
00850051939398 - Exorb Ankle Large2024-08-08 A wound cover that wraps around the ankle which is intended to be used as an initial, short-term treatment after injury that con

Trademark Results [AeroWrap]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AEROWRAP
AEROWRAP
74078708 1694903 Dead/Cancelled
FPM, INC.
1990-07-16
AEROWRAP
AEROWRAP
73750051 1704856 Dead/Cancelled
BXL PLASTICS LIMITED
1988-09-06
AEROWRAP
AEROWRAP
73674182 1479604 Live/Registered
SALEM LABEL COMPANY, INC.
1987-07-24

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