Product code BZO
- Device name
- Set, Tubing And Support, Ventilator (W Harness)
- Medical specialty
- Anesthesiology
- Device class
- 1
- Regulation number
- 868.5975
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K953784 | UNICOR, INC. CORRUGATED TUBING | Unicor, Inc. | 1995-09-19 |
| K953785 | UNICOR, INC. VENTILATOR HOSES | Unicor, Inc. | 1995-09-18 |
| K952010 | PRIMA VENTILATOR HOSES | Prima, Inc. | 1995-05-22 |
| K952011 | PRIMA BREATHING BAGS | Prima, Inc. | 1995-05-22 |
| K952012 | PRIMA CUSTOM ANESTESIA CIRCUIT | Prima, Inc. | 1995-05-22 |
| K952022 | PRIMA VOLUMN VENTILATORSS | Prima, Inc. | 1995-05-22 |
| K945740 | INFANT FLOW SYSTEM | Hamilton Medical, Inc. | 1995-03-23 |
| K944531 | PRIMA, INC. CORRUGATED TUBING | Prima, Inc. | 1994-12-02 |
| K942569 | VENTILATOR HOSE | Med-Plastics Intl., Inc. | 1994-06-10 |
| K942572 | VOLUME VENTILATOR | Med-Plastics Intl., Inc. | 1994-06-10 |
| K935582 | TUBE, INHALER OXYGEN | Puritas Health Care, Inc. | 1994-01-14 |
| K934753 | STAR BREATHING CIRCUITS | Infrasonics Corp. | 1993-10-27 |
| K932706 | PRECISION MED PRODUCTS LTD. VENTILATOR HOSE | Precision Med Products, Ltd. | 1993-07-23 |
| K932560 | VOLUME VENTILATORS | Life Shield Healthcare Products, Inc. | 1993-07-22 |
| K932712 | PRECISION MED PRODUCTS LTD VOLUME VENTILATORS | Precision Med Products, Ltd. | 1993-07-22 |
| K932563 | VENTILATOR HOSES | Life Shield Healthcare Products, Inc. | 1993-07-16 |
| K932119 | CLEVELAND TUBING, INC. VENTILATOR HOSES | Cleveland Tubing, Inc. | 1993-06-23 |
| K922479 | DISPOSABLE ANESTHESIA BREATHING CIRCUIT, MODIFIED | Intertech Resources, Inc. | 1992-10-30 |
| K921510 | GAS SAMPLING KIT MODIFICATION | Respiratory Support Products, Inc. | 1992-06-11 |
| K911328 | UNIVERSAL VOLUME VENTILATOR CIRCUIT, MODIFICATION | Intertech Resources, Inc. | 1991-08-15 |
| K903083 | NEONATAL VENTILATOR CIRCUIT | Hudson Respiratory Care, Inc. | 1990-12-27 |
| K903055 | EXTENDED LIFE CIRCUITS | Pharma Systems, Inc. | 1990-11-09 |
| K903404 | FLOCARE F | Flocare Medical | 1990-09-25 |
| K896439 | TUBING FLEXIBLE MEDICAL GAS LOW-PRESSURE | Ventlab Corp. | 1990-01-09 |
| K895853 | SECHRIST DISPOSABLE INFANT BREATHING CIRCUIT | Sechrist Industries, Inc. | 1989-12-22 |
| K893760 | CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004 | Nova-Ventrx | 1989-08-10 |
| K890822 | CIRCUIT BREATHING (W CONNECTOR, ADAPTER Y PIECE) | Ventlab Corp. | 1989-05-05 |
| K890011 | OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING | Life Design Systems, Inc. | 1989-03-20 |
| K884525 | PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORT | Intertech/Ohio | 1988-12-16 |
| K882341 | QUICK CONNECT T ADAPTOR | Thayer Medical Corp. | 1988-07-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04055146499146 | Breathing set, unheated | WILAmed GmbH | 2026-10-20 |
| 04055146499467 | Breathing set, unheated | WILAmed GmbH | 2026-10-20 |
| 04055146499474 | Breathing set, unheated | WILAmed GmbH | 2026-10-20 |
| 04055146499481 | Breathing set, unheated | WILAmed GmbH | 2026-10-20 |
| 04055146499498 | Breathing set, unheated | WILAmed GmbH | 2026-10-20 |
| 04055146499634 | Breathing set, unheated | WILAmed GmbH | 2026-10-20 |
| 04055147001393 | Breathing set, unheated | WILAmed GmbH | 2026-10-20 |
| 04055147001409 | Breathing set, unheated | WILAmed GmbH | 2026-10-20 |
| 04055146499122 | Breathing set, unheated | WILAmed GmbH | 2026-10-20 |
| 04055146040935 | Breathing set, unheated | WILAmed GmbH | 2026-10-19 |
| 04048675826316 | Anesthesia Set Coax GSL 180 | Drägerwerk AG & Co. KGaA | 2026-10-15 |
| 04048675826088 | VentStar Coax GSL 180 | Drägerwerk AG & Co. KGaA | 2026-10-15 |
| 05404013001521 | Classic | Plastiflex Group | 2026-09-21 |
| 05404013001507 | Classic | Plastiflex Group | 2026-09-21 |
| 04026704388868 | HUDSON RCI | TELEFLEX INCORPORATED | 2025-07-30 |
| 04026704388783 | HUDSON RCI | TELEFLEX INCORPORATED | 2025-07-30 |
| 04026704388790 | HUDSON RCI | TELEFLEX INCORPORATED | 2025-07-30 |
| 04026704388820 | HUDSON RCI | TELEFLEX INCORPORATED | 2025-07-30 |
| 04026704388837 | HUDSON RCI | TELEFLEX INCORPORATED | 2025-07-30 |
| 04026704388844 | HUDSON RCI | TELEFLEX INCORPORATED | 2025-07-30 |
| 04026704388851 | HUDSON RCI | TELEFLEX INCORPORATED | 2025-07-30 |
| 00818834028134 | Curaplex | TRI-ANIM HEALTH SERVICES, INC. | 2019-07-01 |
| 00848530070052 | Sunset Healthcare Durable CPAP Tubing 4 Foot 19mm I.D. with 22mm Cuffs Gray | Sunset Healthcare Solutions, Inc. | 2018-09-19 |
| 00848530070076 | Sunset Healthcare Durable CPAP Tubing 6 Foot 19mm I.D. with 22mm Cuffs Gray | Sunset Healthcare Solutions, Inc. | 2018-09-19 |
| 00848530070175 | **Pressure Line** Sunset Healthcare Durable CPAP Tubing 6 Foot 19mm I.D. with | Sunset Healthcare Solutions, Inc. | 2018-09-19 |
| 00848530070021 | Sunset Healthcare Durable CPAP Tubing 2 Foot 19mm I.D. with 22mm Cuffs Gray | Sunset Healthcare Solutions, Inc. | 2018-09-19 |
| 00848530070007 | "Sunset Healthcare Durable CPAP Tubing 18"" 19mm I.D. with 22mm Cuffs Gray" | Sunset Healthcare Solutions, Inc. | 2018-09-19 |
| 04026704388776 | HUDSON RCI | TELEFLEX INCORPORATED | 2018-09-15 |
| 04026704388769 | HUDSON RCI | TELEFLEX INCORPORATED | 2018-09-15 |
| 00818834020350 | Curaplex | TRI-ANIM HEALTH SERVICES, INC. | 2017-04-18 |