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Aerowrap® Full Leg Tall Flex FL-FL-MLL-L-SFT-M

by Sun-Scientific Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850070012652 UDI-DI Date12 Jun 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Aerowrap® Full Leg Tall Flex
Generic Name
Multi-chamber venous compression system garment, single-use
Model / Ref / Catalog
FL-FL-MLL-L-SFT-M
Primary DI / UDI-DI
00850070012652
FDA Product Code
MHW
GMDN Term
Multi-chamber venous compression system garment, single-use
Device Class
Class I
Regulation Number
880.5075
GUDID distribution status
In Commercial Distribution

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Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No