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Ocs Heart Leukocyte Depleting Filter 1466

by TransMedics, 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB00962623 UDI-DI Date4 May 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  • Withdrawn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
Ocs Heart Leukocyte Depleting Filter
Generic Name
Donor-organ preservation/transport perfusion initiation/termination set
Model / Ref / Catalog
1466
Primary DI / UDI-DI
B00962623
FDA Product Code
DTM
GMDN Term
Donor-organ preservation/transport perfusion initiation/termination set
Device Class
Class II
Regulation Number
870.4260
GUDID distribution status
In Commercial Distribution

Other devices from TransMedics, Inc

See all devices from TransMedics, Inc →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

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