HIgH-Flo™ Needle Set SUPER52604

• FDA 510(k) K180843 decided 4 Apr 2019 Active
• FDA GUDID UDI-DI 00659443002982 listed 16 May 2019 Listed

1. 4 Apr 2019 Cleared FDA 510(k) K180843
2. 16 May 2019 Listed FDA GUDID 00659443002982

Trade name

HIgH-Flo™ Needle Set

Generic name

Subcutaneous infusion/injection port needle

Model / Ref / Catalog

SUPER52604

Primary DI / UDI-DI

00659443002982

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

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• OPTFlow OPT32612U by EMED Technologies Corporation

• RMS Precision Flow Rate TubingTM F60

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

• RMS Precision Flow Rate TubingTM F3

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

• HIgH-Flo™ Needle Set RMS12609

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• 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. →