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Portex 4895CS

by ICU Medical, Inc.

Portex 4895CS is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K110053 on 14 Sep 2012 and listed in FDA GUDID since 9 Jan 2017 (UDI-DI 20351688077568), 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) K110053

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 Number20351688077568 UDI-DI Date9 Jan 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK110053 Date14 Sep 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K110053 decided 14 Sep 2012 Active
  • FDA GUDID UDI-DI 20351688077568 listed 9 Jan 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K110053
  2. Listed FDA GUDID 20351688077568

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Portex
Generic name
Metered-delivery hypodermic syringe
Model / reference
4895CS
Primary DI / UDI-DI
20351688077568
510(k) Number
FDA product code
CAZ
GMDN term
Metered-delivery hypodermic syringe
Device class
Class II
Regulation number
868.5140
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code CAZ (Anesthesia conduction kit).

Other devices from ICU Medical, Inc.

See all devices from ICU Medical, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)