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Carpediem IB0595580

by Mozarc Medical Italy SRL GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08051684580090 UDI-DIDate30 Jul 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Carpediem
Generic Name
Haemodialysis/haemofiltration system component set
Model / Reference
IB0595580
Primary DI / UDI-DI
08051684580090
De Novo Number
FDA Product Code
QIR
GMDN Term
Haemodialysis/haemofiltration system component set
Device Class
Class II
Regulation Number
876.5861
GUDID distribution status
In Commercial Distribution
Size
Area/Surface Area — 0.25 Square meter

Related devices

Cleared under the same submission (DEN180055)

Other devices from Mozarc Medical Italy SRL

Properties

  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No