Skip to content

Jelco 96000S

by ICU Medical, Inc.

Jelco 96000S is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K923090 on 1 Sep 1992 and listed in FDA GUDID since 9 Jan 2017 (UDI-DI 20351688074680), 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) K923090

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 Number20351688074680 UDI-DI Date9 Jan 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK923090 Date1 Sep 1992DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K923090 decided 1 Sep 1992 Active
  • FDA GUDID UDI-DI 20351688074680 listed 9 Jan 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K923090
  2. Listed FDA GUDID 20351688074680

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Jelco
Generic name
Blood collection tube holder, single-use
Model / reference
96000S
Primary DI / UDI-DI
20351688074680
510(k) Number
FDA product code
JKA
GMDN term
Blood collection tube holder, single-use
Device class
Class II
Regulation number
862.1675
GUDID distribution status
In Commercial Distribution

Related devices

Category: Blood collection tube holder, single-use

Cleared under the same submission (K923090)

and 3 more cleared under K923090

Similar devices

Other devices filed under FDA product code JKA (Tubes, vials, systems, serum separators, blood collection).

Other devices from ICU Medical, Inc.

See all devices from ICU Medical, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)