Delta Fly® 3685222

• FDA 510(k) K140175 decided 5 Aug 2014 Active
• FDA GUDID UDI-DI 08032248368521 listed 23 Sep 2016 Listed

1. 5 Aug 2014 Cleared FDA 510(k) K140175
2. 23 Sep 2016 Listed FDA GUDID 08032248368521

Trade name

Delta Fly®

Generic name

Venous butterfly needle/set

Model / reference

3685222

Primary DI / UDI-DI

08032248368521

510(k) Number

K140175 ↗

FDA product code

FPA

GMDN term

Venous butterfly needle/set

Device class

Class II

Regulation number

880.5440

GUDID distribution status

In Commercial Distribution

Size

Pore Size — 20 Micrometer

Outer Diameter — 0.6 Millimeter

Length — 20 Millimeter

Needle Gauge — 23 Gauge

Category: Venous butterfly needle/set

Other devices filed under FDA product code FPA (Set, Administration, Intravascular).

• AMSafe® I.V. Administration Set with Preattached Extension Set 1 108305 by AMSINO INTERNATIONAL, INC.
• AMSafe® Extension Set 1 MR3108 by AMSINO INTERNATIONAL, INC.
• FlowArt® AF6112 by ASSET MEDIKAL TASARIM SANAYI VE TICARET ANONIM SIRKETI
• CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1 by Sims Deltec, Inc.
• CLIRANS PRIMING SET by TERUMO MEDICAL CORPORATION
• SAFELINE SYSTEM IV ADMINISTRATION SETS & COMPONENT by Mcgaw, Inc.
• MAERSK MEDICAL CONTOUR INFUSION SET by Maersk Medical A/S
• BD Vacutainer® UltraTouch™ Push Button Blood Collection Set with PAH 368684 by Becton, Dickinson and Company
• INFUSION SET TYPE J by Berman, Pcp & Consultants, Inc.
• SIMPLICITY EASY ACCESS INFUSION SET by Sterling Medivations, Inc.

• PICC Assembled System

  Class I

  CE/MDR

• Assembled Midline Catheter System

  Class I

  CE/MDR

• Cesarean section assembled system

  Class I

  CE/MDR

• Kit PICC Power Injectable

  Class I

  CE/MDR

See all devices from Delta Med SpA →