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Organ Care System 1411

by TransMedics, Inc 2 variants

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 NumberB00972500 UDI-DI Date10 Sep 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  • Withdrawn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
Organ Care System
Generic Name
Surgical/procedural instrument trolley
Model / Ref / Catalog
1411
Primary DI / UDI-DI
B00972500
FDA Product Code
QBA, QIK, QQK
GMDN Term
Surgical/procedural instrument trolley
Device Class
Class III
GUDID distribution status
In Commercial Distribution
Size
Length — 21 Inch
Width — 28 Inch
Height — 10 Inch

Other devices from TransMedics, Inc

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Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No