Product Classification

• Device: pump, infusion, ophthalmic
• Regulation Description: Infusion pump.
• Regulation Medical Specialty: General Hospital
• Review Panel: Ophthalmic
• Product Code: MRH
• Submission Type: 510(k)
• Regulation Number: 880.5725
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standard

• ISO 23908 First edition 2011-06-11 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.