Polyperf Safe U101908

• FDA 510(k) K063631 decided 5 Oct 2007 Active
• FDA GUDID UDI-DI 03661234013937 listed 16 Sep 2016 Listed

1. 5 Oct 2007 Cleared FDA 510(k) K063631
2. 16 Sep 2016 Listed FDA GUDID 03661234013937

Trade name

Polyperf Safe

Generic name

Subcutaneous infusion/injection port needle

Model / reference

U101908

Primary DI / UDI-DI

03661234013937

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).

• SAFE-POINT VAC, SAFE-POINT M-D BLOOD COLLECTION SYSTEMS by North American Medical Products, Inc.
• B-D GUARDIAN NESTABLE SHARPS COLLECTORS by Med-Safe Systems, Inc.
• DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE by Disetronic Medical Systems
• NON-KOR WINGED INFUSION SETS by Creative Care Systems, Inc.
• Adult Intraosseous Infusion Device by EINSTEIN WORKS, LLC
• Verisafe Safety sterile needles by Promisemed Hangzhou Meditech Co., Ltd.
• LIFE LATCH SHARPS & BIOHAZARD CONTAINER by M&M Industries, Inc.
• VACUETTE PREMIUM SAFETY NEEDLE SYSTEM TUBE-TOUCH by Medpro Safety Products, Inc.
• ARROW IPN923045 9018-VC-005 by TELEFLEX INCORPORATED
• STAT MEDICAL PEN NEEDLE by Emergogroup, 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 →