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Cadd 21-6220-64

by ICU Medical, Inc.

Cadd 21-6220-64 is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K982839 on 2 Nov 1998 and listed in FDA GUDID since 13 Oct 2016 (UDI-DI 10610586035098), 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) K982839

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 Number10610586035098 UDI-DI Date13 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK982839 Date2 Nov 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K982839 decided 2 Nov 1998 Active
  • FDA GUDID UDI-DI 10610586035098 listed 13 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K982839
  2. Listed FDA GUDID 10610586035098

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Cadd
Generic name
Infusion pump remote control
Model / reference
21-6220-64
Primary DI / UDI-DI
10610586035098
510(k) Number
FDA product code
MEA
GMDN term
Infusion pump remote control
Device class
Class II
Regulation number
880.5725
GUDID distribution status
In Commercial Distribution

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Properties

  • Lot / batch number
Other properties (14, all answered No)