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Flying-V - finger cuff (medium) G2

by CNSystems Medizintechnik AG

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 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 Number09120073930545 UDI-DI Date27 Oct 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-0572-2016 FDA Class II initiated 1 Dec 2015 on shared 510(k) K014063

    Device non-conformity which may lead to an incorrect oscillometric measurement of upper arm blood pressure values in some subjects - mainly in tall and slim persons (overestimation of systolic blood pressure, underestimation of diastolic blood pressure).

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Flying-V - finger cuff (medium)
Generic Name
Noninvasive haemodynamic monitoring system
Model / Ref / Catalog
G2, 00055
Primary DI / UDI-DI
09120073930545
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 (K014063)

Show all (12)

Properties

  • Lot / Batch Number

Other properties (13)

  • 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No