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Flexicap Disconnect Cap with Povidone-Iodine Solution 5C4456

by Vantive US Healthcare, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

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 Number07332414208011 UDI-DI Date30 Jan 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1213-2023 FDA Class II initiated 1 Feb 2023

    MiniCap Disconnect Cap with Povidone-Iodine are packaged in foil pouches, which may have been incorrectly sealed, i.e., the pouches may have open or weak seals. This could lead to exposure to air, resulting in insufficient iodine/dry sponge inside the MiniCap, which could lead to the potential for inadequate disinfectant.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Flexicap Disconnect Cap with Povidone-Iodine Solution
Generic Name
Peritoneal dialysis system tubing set
Model / Ref / Catalog
5C4456
Primary DI / UDI-DI
07332414208011
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 (K152129)

Other devices from Vantive US Healthcare, LLC

See all devices from Vantive US Healthcare, LLC →

Properties

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

Other properties (9)

  • 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