Absorbent, Carbon-dioxide

Device Code: 101

Product Code(s): CBL

Device Classification Information

Device Type ID101
Device NameAbsorbent, Carbon-dioxide
Regulation DescriptionCarbon Dioxide Absorbent.
Regulation Medical SpecialtyAnesthesiology
Review PanelAnesthesiology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Respiratory Devices Branch (RPDB)
Submission Type510(K) Exempt
CFR Regulation Number868.5300 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeCBL
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID101
DeviceAbsorbent, Carbon-dioxide
Product CodeCBL
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionCarbon Dioxide Absorbent.
CFR Regulation Number868.5300 [🔎]
Device Problems
Break
1
Total Device Problems 1
TPLC Last Update: 2019-04-02 19:29:05

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