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d-Nav® V1m00b053d

by Hygieia, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860001044218 UDI-DI Date5 Apr 2019ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
d-Nav®
Generic Name
Calculator, programmable
Model / Reference
V1m00b053d
Primary DI / UDI-DI
00860001044218
510(k) Number
FDA Product Code
NDC
GMDN Term
Calculator, programmable
Device Class
Class II
Regulation Number
868.1890
GUDID distribution status
In Commercial Distribution

Related devices

Category: Calculator, programmable

Cleared under the same submission (K181916)

Other devices from Hygieia, Inc.

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: 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