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Manifold Set L5C4446

by Vantive US Healthcare, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

2 closed

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 Number07332414208417 UDI-DI Date22 Jun 2026ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · FDA

    • Terminated Z-0194-2016 FDA Class II initiated 6 Oct 2015

    Leakage from the inlet port of the 15L Cycler Drainage Bags.

    • Terminated Z-0080-2015 FDA Class II initiated 17 Oct 2013

    The large tube clamp used to close the drain tube on the 15 L Cycler Drainage Bag may not fully close the drain tube and may result in leakage.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Manifold Set
Generic Name
Peritoneal dialysis system tubing set
Model / Ref / Catalog
L5C4446
Primary DI / UDI-DI
07332414208417
510(k) Number
FDA Product Code
KDJ
GMDN Term
Peritoneal dialysis system tubing set
Device Class
Class II
Regulation Number
876.5630
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K791899)

Other devices from Vantive US Healthcare, LLC

See all devices from Vantive US Healthcare, LLC →

Properties

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

Other properties (9)

  • 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