Injector, Fluid, Non-electrically Powered

Device Code: 2643

Product Code(s): KZE

Device Classification Information

• Device Type ID: 2643
• Device Name: Injector, Fluid, Non-electrically Powered
• Regulation Description: Nonelectrically Powered Fluid Injector.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); General Hospital Devices Branch (GHDB)
• Submission Type: 510(k)
• CFR Regulation Number: 880.5430 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: KZE
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 6-179 ISO 21649 First Edition 2006-06-01
  Needle-free Injectors For Medical Use -- Requirements And Test Methods

Total Product Life Cycle

• Device Type ID: 2643
• Device: Injector, Fluid, Non-electrically Powered
• Product Code: KZE
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Nonelectrically Powered Fluid Injector.
• CFR Regulation Number: 880.5430 [🔎]

Device Problems
Adverse Event Without Identified Device Or Use Problem	5
Total Device Problems	5

TPLC Last Update: 2019-04-02 20:16:38