AeroWrap™ Flex Extra Large Bilateral - The AeroWrap ™ Flex System is comprised of a - SUN SCIENTIFIC, INC.

Duns Number:609397224

Device Description: The AeroWrap ™ Flex System is comprised of a gradient compression sleeve, and hand pump to 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.

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More Product Details

Catalog Number

MSB-XLF

Brand Name

AeroWrap™ Flex Extra Large Bilateral

Version/Model Number

Extra Large Flex Bi

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

October 31, 2030

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K070457

Product Code Details

Product Code

MHW

Product Code Name

Dressing, Compression

Device Record Status

Public Device Record Key

48b43e2e-153f-4565-a4b0-a96f9686f78b

Public Version Date

June 23, 2022

Public Version Number

2

DI Record Publish Date

April 15, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SUN SCIENTIFIC, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 46
2 A medical device with a moderate to high risk that requires special controls. 30