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ExtriCARE EC-DOME

by Alleva Medical, Ltd.

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04897089070163 UDI-DI Date3 Dec 2025ListedStatusListed 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  • Withdrawn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
ExtriCARE
Generic Name
Negative-pressure wound therapy tubing set
Model / Ref / Catalog
EC-DOME, ST401
Primary DI / UDI-DI
04897089070163
FDA Product Code
OMP
GMDN Term
Negative-pressure wound therapy tubing set
Device Class
Class II
Regulation Number
878.4780
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide

Other devices from Alleva Medical, Ltd.

See all devices from Alleva Medical, Ltd. →

Properties

  • Sterile
  • Single Use
  • Contains Latex
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (6)

  • Implantable: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No