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Empty Sterile Container 5C4462

by Vantive US Healthcare, LLC

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 Number07332414208325 UDI-DI Date30 Jun 2026ListedStatusListed 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  • Withdrawn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

Trade Name
Empty Sterile Container
Generic Name
Peritoneal dialysis system tubing set
Model / Ref / Catalog
5C4462
Primary DI / UDI-DI
07332414208325
510(k) Number
FDA Product Code
FKX
GMDN Term
Peritoneal dialysis system tubing set
Device Class
Class II
Regulation Number
876.5630
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 3 Liter

Related devices

Cleared under the same submission (K833065)

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