HIgH-Flo™ Needle Set SUPER12609

• FDA 510(k) K180843 decided 4 Apr 2019 Active
• FDA GUDID UDI-DI 00659443002807 listed 16 May 2019 Listed

1. 4 Apr 2019 Cleared FDA 510(k) K180843
2. 16 May 2019 Listed FDA GUDID 00659443002807

Trade name

HIgH-Flo™ Needle Set

Generic name

Subcutaneous infusion/injection port needle

Model / Ref / Catalog

SUPER12609

Primary DI / UDI-DI

00659443002807

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).

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• neria guard Infusion Set by Unomedical A/S
• Extension Sets by Hospira, Inc.
• PROVIDER BAG SPIKE W/12 MICROBORE EXTEN by Pancretec, Inc.
• SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) by Terumo Europe N.V.
• Precision Delivery Infusion Set by QUEST MEDICAL INC
• FLOW MED 150 by D.R.O. Medical, Inc.
• OPTFlow OPT32606 by EMED Technologies Corporation
• SAF-Q-309-G27 by EMED Technologies Corporation
• SIMPLICITY QD EASY P INFUSION SET by Sterling Medivations, Inc.

• 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 RMS42612

  Class II

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

See all devices from Repro Med Systems, Inc. →