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Novii 107-PT-020

by Monica Healthcare

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number05060433670015 UDI-DI Date12 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Novii
Generic Name
Foetal/maternal prenatal monitor
Model / Reference
107-PT-020
Primary DI / UDI-DI
05060433670015
FDA Product Code
OSP
GMDN Term
Foetal/maternal prenatal monitor
Device Class
Class II
Regulation Number
884.2720
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Unsafe

Other devices from Monica Healthcare

Properties

  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • 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
  • Expiration Date: No