EasyPoint® 26021

• FDA 510(k) K202325 decided 9 Apr 2021 Active
• FDA GUDID UDI-DI 00613703260208 listed 18 Apr 2023 Listed

1. 9 Apr 2021 Cleared FDA 510(k) K202325
2. 18 Apr 2023 Listed FDA GUDID 00613703260208

Trade name

EasyPoint®

Generic name

Blood collection tube holder/needle

Model / Ref / Catalog

26021

Primary DI / UDI-DI

00613703260208

510(k) Number

K202325 ↗

FDA product code

JKA

GMDN term

Blood collection tube holder/needle

Device class

Class II

Regulation number

862.1675

GUDID distribution status

In Commercial Distribution

Category: Blood collection tube holder/needle

Other devices filed under FDA product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection).

• S-Monovette® 06.1665.100 by Sarstedt Aktiengesellschaft & Co.KG
• GREINER VACUETTE BLOOD COLLECTION TUBE by Greiner America, Inc.
• SAFETY NEEDLE by SARSTEDT, INC.
• BD Vacutainer Push Button Blood Collection Set, BD Vacutainer Push Button Blood Collection Set with Pre-Attached Holder by Becton, Dickinson and Company
• Micro-Needle 85.921 by Sarstedt Aktiengesellschaft & Co.KG
• STATSPIN STATSAMPLER by Statspin Technologies
• PIVO™ Pro Needle-free Blood Collection Device by Becton Dickinson Infusion Therapy Systems Inc.
• Kurin Blood Culture Collection Set by PATHWAY, LLC
• Vacuette 450184 by Greiner Bio - One GmbH
• VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE by Becton Dickinson Vacutainer Systems

• VanishPoint Syringe

  Class IIa

  CE/MDR

• VanishPoint® 10154

  Class II

  FDA 510(k) K980069 Active Cleared 12 Feb 1998 GUDID on market

• EasyPoint® 82211 Open recall

  Class II

  CE/MDR FDA 510(k) K133635 Active Cleared 17 Jun 2014 +1authorizations

• VanishPoint® 10301

  Class II

  CE/MDR FDA 510(k) K946219 Active Cleared 28 Dec 1995 +1authorizations

See all devices from Retractable Technologies, Inc. →