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Quantum SuperPAC Tubing Set - SP06E-BB

by Spectrum Medical Limited

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number18051160303240 UDI-DI Date17 Oct 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Cardiopulmonary bypass system blood tubing set
Model / Reference
SP06E-BB
Primary DI / UDI-DI
18051160303240
510(k) Number
FDA Product Code
DWF
GMDN Term
Cardiopulmonary bypass system blood tubing set
Device Class
Class II
Regulation Number
870.4210
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K213540)

Show all (11)

Other devices from Spectrum Medical Limited

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Properties

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

Other properties (8)

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