HIgH-Flo™ Needle Set SUPER12604

• FDA 510(k) K180843 decided 4 Apr 2019 Active
• FDA GUDID UDI-DI 00659443002784 listed 16 May 2019 Listed

1. 4 Apr 2019 Cleared FDA 510(k) K180843
2. 16 May 2019 Listed FDA GUDID 00659443002784

Trade name

HIgH-Flo™ Needle Set

Generic name

Subcutaneous infusion/injection port needle

Model / Ref / Catalog

SUPER12604

Primary DI / UDI-DI

00659443002784

510(k) Number

K180843 ↗

FDA product code

FPA

GMDN term

Subcutaneous infusion/injection port needle

Device class

Class II

Regulation number

880.5440

GUDID distribution status

In Commercial Distribution

Sterilisation method

Radiation Sterilization

Size

Needle Gauge — 26 Gauge

Category: Subcutaneous infusion/injection port needle

Other devices filed under FDA product code FPA (Set, administration, intravascular).

• BD Secondary Infusion Set by CAREFUSION
• IVAC NEEDLELESS INJECTION VALVE by Y
• B-D STASET, I.V. FLOW CONTROLLER by Bd Becton Dickinson Vacutainer Systems Preanalytic
• PARADIGM SOF-SET MICRO QR, MODELS 324 AND 325 by Minimed, Inc.
• FLEXNEEDLE PLUS by Act Medical, Inc.
• SMARTSITE ACCESS PIN by Ivac Medical Systems
• CAP, INJECTION (#4600) by Jelco Laboratories
• SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE by Baxter Healthcare Corp
• SUB-Q SUB-400 by EMED Technologies Corporation
• NAC PRN NEEDLELESS ACCESS CONNECTOR by The Kipp Group

• RMS Precision Flow Rate TubingTM F60

  Class II

  CE/MDD FDA 510(k) K933652 Active Cleared 18 May 1994 +1authorizations

• RMS Precision Flow Rate TubingTM F3

  Class II

  CE/MDD FDA 510(k) K933652 Active Cleared 18 May 1994 +1authorizations

• HIgH-Flo™ Needle Set RMS12609

  Class II

  CE/MDD FDA 510(k) ×5 Active Cleared 6 May 2013 +1authorizations

• HIgH-Flo™ Needle Set SUPER12609

  Class II

  FDA 510(k) K180843 Active Cleared 4 Apr 2019 GUDID on market

See all devices from Repro Med Systems, Inc. →