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Primo Passi JPD-FR300

by Primo Passi

Listed FDA GUDID listing, no authorization on record

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 Number00850000125469 UDI-DI Date27 Mar 2026ListedStatusListed GUDID: 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  • Withdrawn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
Primo Passi
Generic Name
Infrared patient thermometer, ear/skin
Model / Ref / Catalog
JPD-FR300, SK-158
Primary DI / UDI-DI
00850000125469
510(k) Number
FDA Product Code
FLL
GMDN Term
Infrared patient thermometer, ear/skin
Device Class
Class II
Regulation Number
880.2910
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K131243)

Show all (12)

Other devices from Primo Passi

Properties

  • Over-the-Counter
  • Lot / Batch Number
  • Serial Number

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No
  • Manufacturing Date: No