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Operator's Manual English USA V3.5.3

by CNSystems Medizintechnik AG

Listed FDA GUDID listing, not in commercial distribution

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 Number09120073931344 UDI-DI Date22 Sep 2017ListedStatusListed GUDID: not 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  • Withdrawn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
Operator's Manual English USA
Generic Name
Noninvasive haemodynamic monitoring system
Model / Ref / Catalog
V3.5.3, 21-FHZU-10002
Primary DI / UDI-DI
09120073931344
510(k) Number
FDA Product Code
DXN
GMDN Term
Noninvasive haemodynamic monitoring system
Device Class
Class II
Regulation Number
870.1130
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K082599)

Show all (12)

Properties

Other properties (14)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No