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Quadrox iD ECC Pack BEQ-TOP 28800

by Datascope Corp.

Quadrox iD ECC Pack BEQ-TOP 28800 (701052034R01) is a Class II device made by Datascope Corp., listed in FDA GUDID since 18 Jul 2018 (UDI-DI 00607567212350), not in commercial distribution (GUDID) as of 23 Oct 2026.

Listed FDA GUDID listing, not in commercial distribution

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00607567212350 UDI-DI Date18 Jul 2018ListedStatusListed GUDID: not in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Quadrox iD ECC Pack
Generic name
Cardiopulmonary bypass system blood tubing set
Model / Ref / Catalog
BEQ-TOP 28800, 701052034R01
Primary DI / UDI-DI
00607567212350
FDA product code
DWE
GMDN term
Cardiopulmonary bypass system blood tubing set
Device class
Class II
Regulation number
870.4390
GUDID distribution status
Not in Commercial Distribution
Sterilisation method
Ethylene Oxide

Similar devices

Other devices filed under FDA product code DWE (Tubing, Pump, Cardiopulmonary Bypass).

Other devices from Datascope Corp.

See all devices from Datascope Corp. →

Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (7, all answered No)