Product code BYD
- Device name
- Condenser, Heat And Moisture (Artificial Nose)
- Medical specialty
- Anesthesiology
- Device class
- 1
- Regulation number
- 868.5375
- 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 |
|---|---|---|---|
| K955008 | HEAT & MOISTURE EXCHANGER | Intertech Resources, Inc. | 1996-01-30 |
| K954194 | DISPOSABLE HME/FILTER | Engstrom Medical | 1995-10-20 |
| K953580 | HEAT MOISTURE EXCHANGER | Intertech Resources, Inc. | 1995-09-15 |
| K953507 | TYPE 1 & 2 (HUMIDAIR I & II) | Icor AB | 1995-09-07 |
| K953491 | HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE | Gibeck, Inc. | 1995-08-25 |
| K953540 | EEE | Edentec Corp. | 1995-08-25 |
| K953544 | HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT | Gibeck, Inc. | 1995-08-25 |
| K953619 | WARM N WET HME W/LUER ADAPTER | Hospitak, Inc. | 1995-08-25 |
| K953620 | WARM N WET HMEF W/LUER ADAPTER | Hospitak, Inc. | 1995-08-25 |
| K952845 | HUMID-VENT TRACH-VENT | Gibeck, Inc. | 1995-07-25 |
| K952750 | HUMID-VENT 1 | Gibeck, Inc. | 1995-07-20 |
| K952844 | HUMID-VENT 2 | Gibeck, Inc. | 1995-07-20 |
| K952823 | FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE | Icor AB | 1995-07-13 |
| K952084 | HUMID-VENT FILTER PEDI | Gibeck, Inc. | 1995-06-12 |
| K946209 | DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME | Med-Plastics Intl., Inc. | 1995-06-08 |
| K952036 | FLEXLIFE | Mallinckrodt Medical | 1995-06-08 |
| K951856 | HUMID-VENT MICRO | Gibeck, Inc. | 1995-06-07 |
| K945359 | AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H | Artema Medical AB | 1995-02-21 |
| K950447 | FILTER/HCH PRODUCT NUMBER 5710HEPA, 5710FILT | Vital Signs, Inc. | 1995-02-21 |
| K945657 | DISPOSABLE HEAT AND MOSITURE EXCHANGER AND HME/FILTER | Tec II Medical, Inc. | 1994-12-07 |
| K943915 | HEAT AND MOISTURE EXCHANGER FILTER (HME) | Medicomp, Inc. | 1994-10-14 |
| K944194 | DISPOSABLE HEAT & MOSITURE EXCHANGER & FILTER/HME | Med-Tek Innovations, Inc. | 1994-09-13 |
| K942794 | HYGROLIFE | Mallinckrodt Medical | 1994-08-22 |
| K941987 | HEAT AND MOISTURE EXCHANGERS AND FILTERS | Icor AB | 1994-08-15 |
| K941436 | AFH, AFH FLEX, AFH/T, AFH/T FLEX, AF | Icor AB | 1994-06-08 |
| K941813 | VENSHIELD | Cybermedic, Inc. | 1994-05-03 |
| K941585 | HYGROSTER | Mallinckrodt Medical | 1994-04-19 |
| K941535 | TRACHEOLIFE | Mallinckrodt Medical | 1994-04-15 |
| K935036 | HEPA FILTERED HEAT AND MOISTURE EXCHANGER | Intertech Resources, Inc. | 1994-01-25 |
| K934441 | KING SYSTEMS HME | King Systems Corp. | 1993-12-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00848530106430 | Heat Moisture Exchanger | Sunset Healthcare Solutions, Inc. | 2026-08-15 |
| 00848530107284 | Heat Moisture Exchanger | Sunset Healthcare Solutions, Inc. | 2025-08-19 |
| 00848530096953 | Heat Moisture Exchanger | Sunset Healthcare Solutions, Inc. | 2024-07-31 |
| 00848530096946 | Heat Moisture Exchanger | Sunset Healthcare Solutions, Inc. | 2024-07-31 |
| 00848530096922 | Heat Moisture Exchanger | Sunset Healthcare Solutions, Inc. | 2024-07-31 |
| 00848530096908 | Heat Moisture Exchanger | Sunset Healthcare Solutions, Inc. | 2024-07-31 |
| 00848530103637 | Heat Moisture Exchanger | Sunset Healthcare Solutions, Inc. | 2024-07-31 |
| 00848530062316 | Heat Moisture Exchanger | Sunset Healthcare Solutions, Inc. | 2024-07-31 |
| 00848530083298 | Heat Moisture Exchanger | Sunset Healthcare Solutions, Inc. | 2024-06-28 |
| 00848530083274 | Heat Moisture Exchanger | Sunset Healthcare Solutions, Inc. | 2024-06-28 |
| 07331791015854 | TrachPhone (5 pcs) | Atos Medical AB | 2023-06-19 |
| 07331791009693 | TrachPhone (30 pcs) | Atos Medical AB | 2022-11-29 |
| 07331791002861 | TrachPhone (50 pcs) | Atos Medical AB | 2022-11-29 |
| 00848530082017 | Sunset Healthcare Mini in-line HME, for neonatal | Sunset Healthcare Solutions, Inc. | 2018-09-21 |
| 00848530083434 | Sunset T HME with built-in Oxygen Port | Sunset Healthcare Solutions, Inc. | 2018-09-20 |
| 00848530089054 | Sunset Flex HME | Sunset Healthcare Solutions, Inc. | 2018-09-17 |
| 04026704399086 | HUDSON RCI | TELEFLEX INCORPORATED | 2018-09-15 |
| 04026704399048 | HUDSON RCI | TELEFLEX INCORPORATED | 2018-09-15 |
| 04026704399055 | HUDSON RCI | TELEFLEX INCORPORATED | 2018-09-15 |
| 04026704399062 | HUDSON RCI | TELEFLEX INCORPORATED | 2018-09-15 |
| 04026704399079 | HUDSON RCI | TELEFLEX INCORPORATED | 2018-09-15 |
| 04026704347810 | HUDSON RCI | TELEFLEX INCORPORATED | 2018-09-15 |
| 04026704390021 | HUDSON RCI | TELEFLEX INCORPORATED | 2018-09-15 |
| 04026704348190 | HUDSON RCI | TELEFLEX INCORPORATED | 2018-09-15 |
| 04026704348176 | HUDSON RCI | TELEFLEX INCORPORATED | 2018-09-15 |
| 04026704348145 | HUDSON RCI | TELEFLEX INCORPORATED | 2018-09-15 |
| 04026704347926 | HUDSON RCI | TELEFLEX INCORPORATED | 2018-09-15 |
| 04026704347919 | HUDSON RCI | TELEFLEX INCORPORATED | 2018-09-15 |
| 04026704347872 | HUDSON RCI | TELEFLEX INCORPORATED | 2018-09-15 |
| 04026704347865 | HUDSON RCI | TELEFLEX INCORPORATED | 2018-09-15 |