Oxygen Administration Kit

Device Code: 192

Product Code(s): OGL

Definition: This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.Fda.Gov/cdrh/ode/convkit.Html. This Kit, As Described In The Guidance Above, Is Under Enforcemen

Device Classification Information

• Device Type ID: 192
• Device Name: Oxygen Administration Kit
• Physical State: This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Kit, As Described In The Guidance Above, Is Under Enforcemen
• Technical Method: This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Kit, As Described In The Guidance Above, Is Under Enforcemen
• Target Area: This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Kit, As Described In The Guidance Above, Is Under Enforcemen
• Regulation Description: Portable Liquid Oxygen Unit.
• Regulation Medical Specialty: Anesthesiology
• Review Panel: Anesthesiology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); Anesthesiology Devices Branch (ANDB)
• Submission Type: Enforcement Discretion
• CFR Regulation Number: 868.5655 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: OGL
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 192
• Device: Oxygen Administration Kit
• Product Code: OGL
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Portable Liquid Oxygen Unit.
• CFR Regulation Number: 868.5655 [🔎]

Device Problems
Moisture Or Humidity Problem	9
Disconnection	2
Total Device Problems	11

TPLC Last Update: 2019-04-02 19:30:24