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Braun PC20NAFFV1

by Kaz USA, Inc.

Braun PC20NAFFV1 is a Class II device made by Kaz USA, Inc., cleared under FDA 510(k) K103800 on 26 Jan 2011 and listed in FDA GUDID since 29 Aug 2016 (UDI-DI 00328785000313), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K103800

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00328785000313 UDI-DI Date29 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK103800 Date26 Jan 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K103800 decided 26 Jan 2011 Active
  • FDA GUDID UDI-DI 00328785000313 listed 29 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K103800
  2. Listed FDA GUDID 00328785000313

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Braun
Generic name
Electronic thermometer probe cover
Model / reference
PC20NAFFV1
Primary DI / UDI-DI
00328785000313
FDA product code
FLL
GMDN term
Electronic thermometer probe cover
Device class
Class II
Regulation number
880.2910
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electronic thermometer probe cover

Cleared under the same submission (K103800)

and 8 more cleared under K103800

Similar devices in this category

Other devices filed under Electronic thermometer probe cover.

Other devices from Kaz USA, Inc.

See all devices from Kaz USA, Inc. →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
Other properties (12, all answered No)