Product Classification

• Device: valve, non-rebreathing
• Regulation Description: Nonrebreathing valve.
• Regulation Medical Specialty: Anesthesiology
• Review Panel: Anesthesiology
• Product Code: CBP
• Submission Type: 510(k)
• Regulation Number: 868.5870
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ISO 5356-1 Third edition 2004-05-15 Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets
• AS 4259-1995 Ancillary devices for expired air resuscitation

Guidance Document

• Draft Reviewer Guidance on Face Masks and Shield for CPR  

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.