Bottle, Collection And Trap, Breathing System (Uncalibrated)
The Uncalibrated Breathing System Collection and Trap Bottle is a general hospital device used to collect and contain excess or waste fluids from a patient's breathing circuit, preventing contamination of ventilation equipment without providing calibrated volume measurement. It is classified as FDA Class 2 (moderate risk), though it is exempt from 510(k) premarket notification. The product code is CBC, regulated under 21 CFR 880.6740, within the General Hospital medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- CBC
- Device Class
- FDA class 2
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K925422 | BIRD 1000 PV PORTABLE VENTILATOR | May 13, 1993 | Substantially Equivalent | Bird Products Corp. |
| K790035 | AMBU SUCTION BOOSTER | Mar 23, 1979 | Substantially Equivalent | Narco Air-Shields |
| K760082 | BOTTLE, CONDENSATE (#1628) | Jul 16, 1976 | Substantially Equivalent | Inspiron Corp. |
FEI Numbers
This FDA classification entry is associated with 19 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.