21 CFR 880.6740 — Tube, Aspirating, Flexible, Connecting
General Hospital (HO) · Part 880 Subpart G—General Hospital and Personal Use Miscellaneous Devices · § 880.6740
Identification
A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| BYY | Tube, Aspirating, Flexible, Connecting | 2 | 24 | |
| BYZ | Trap, Sterile Specimen | 2 | 9 | |
| CBC | Bottle, Collection And Trap, Breathing System (Uncalibrated) | 2 | 3 | |
| CBD | Bottle, Collection, Breathing System (Calibrated) | 2 | 3 | |
| GAZ | Tubing, Noninvasive | 2 | 27 | |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 2 | 87 | |
| JOL | Catheter And Tip, Suction | 2 | 84 | |
| KDP | Regulator, Vacuum | 2 | 21 | |
| KDQ | Bottle, Collection, Vacuum | 2 | 48 | |
| PAD | Chest Drainage Kit | 2 | 0 |
Special Controls
BYY — Tube, Aspirating, Flexible, Connecting
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
eCFR
BYZ — Trap, Sterile Specimen
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
eCFR
CBC — Bottle, Collection And Trap, Breathing System (Uncalibrated)
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
eCFR
CBD — Bottle, Collection, Breathing System (Calibrated)
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
eCFR
GAZ — Tubing, Noninvasive
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
eCFR
GCX — Apparatus, Suction, Operating-Room, Wall Vacuum Powered
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
eCFR
JOL — Catheter And Tip, Suction
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
eCFR
KDP — Regulator, Vacuum
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
eCFR
KDQ — Bottle, Collection, Vacuum
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
eCFR
PAD — Chest Drainage Kit
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
eCFR
