Polyperf Safe U101906

• FDA 510(k) K063631 decided 5 Oct 2007 Active
• FDA GUDID UDI-DI 03661234013913 listed 18 Sep 2016 Listed

1. 5 Oct 2007 Cleared FDA 510(k) K063631
2. 18 Sep 2016 Listed FDA GUDID 03661234013913

Trade name

Polyperf Safe

Generic name

Subcutaneous infusion/injection port needle

Model / reference

U101906

Primary DI / UDI-DI

03661234013913

510(k) Number

K063631 ↗

FDA product code

FMI

GMDN term

Subcutaneous infusion/injection port needle

Device class

Class II

Regulation number

880.5570

GUDID distribution status

In Commercial Distribution

MRI safety

MR Conditional

Category: Subcutaneous infusion/injection port needle

Other devices filed under FDA product code FMI (Needle, hypodermic, single lumen).

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• ULTICARE DISPOSABLE PEN NEEDLES by ULTI MED, INC.
• INFUSION NEEDLE IIPN by Medi Tex, Inc.
• TERUFUSION BLOOD ADMIN. SET by Terumo America, Inc.
• SHARPS COLLECTION CONTAINER - SAF-T-SHELL by American Medical Mfg., Inc.
• BLOOD COLLECTING NEEDLE AND HOLDERS by Abco Dealers, Inc.
• STERILE INSULIN PEN NEEDLE by SHINA CORP.
• BD Vacutainer Eclipse UltraFill Blood Collection Needle by Becton, Dickinson and Company
• Eclipse DermaFlex Cannula by Eclipse Medcorp, LLC
• Disposable Insulin Pen Needle by Zhejiang Kindly Medical Devices Co., Ltd.

• POLYTHESE ICT STRAIGHT Ø30mm L30cm

  Class III

  CE/MDD

• PPS CT - Safety Huber needle with tubing - pressure injectable - L. 35 mm (1.38 in.) - Ø 1.1 mm (19G)

  Class IIa

  CE/MDD

• PPS Flow+ Safety Huber needle with tubing - Automatic positive flush during removal - with Y-connector - with safety adaptor qimo female - L. 35 mm (1.38 in.) - Ø 1.1 mm (19G)

  Class IIa

  CE/MDD

• POLYPERF Huber needle with tubing - L. 25 mm (1.00 in.) - Ø 1.1 mm (19G)

  Class IIa

  CE/MDD

See all devices from Perouse Medical →