Polyperf Safe U101910

• FDA 510(k) K063631 decided 5 Oct 2007 Active
• FDA GUDID UDI-DI 03661234013944 listed 18 Sep 2016 Listed

1. 5 Oct 2007 Cleared FDA 510(k) K063631
2. 18 Sep 2016 Listed FDA GUDID 03661234013944

Trade name

Polyperf Safe

Generic name

Subcutaneous infusion/injection port needle

Model / reference

U101910

Primary DI / UDI-DI

03661234013944

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

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• TERUFUSION DONOR SET by Terumo America, Inc.
• MODEL TW SB, SCALP VEIN SET; MODEL TW LB, STERILE HYPODERMIC NEEDLE by Shandong Qiaopai Group Co., Ltd.
• BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA by Shandong Weigao Group Medical Polymer Co., Ltd.
• NovoFine Plus 32G Tip x 4 mm by NOVO NORDISK INC.

• 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 →