LTV
Patient Circuit, W/O PEEP, 15mm, SPU, Single Heated Wire, F&P
8manufacturers in China registered for this device type
92catalogue numbers in this listing
1510(k) clearance
4recalls on this code
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (2), Fujian (1). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Respironics Medical Products (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Beijing Aeonmed Co., Ltd. | Sanhe | Hebei | Contract manufacturer | 7 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Vyaire Medical, Inc., United States |
|---|---|
| FDA product code | CBK |
| Device type | Ventilator, Continuous, Facility Use |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5895 |
| 510(k) | K101643 |
| Record published | 2024-08-12 |
| Record revised | 2026-05-18 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature -20 to 60 °C |
| Packaging | Case of 10, pack of 10, case of 5, case of 50, pack of 5 |
| Distribution end date | 2024-08-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 15090-104 | In distribution | |
| 29699-001 | In distribution | |
| 10779 | In distribution | |
| 10695 | In distribution | |
| 29701-001 | In distribution | |
| 21180-001 | In distribution | |
| 15090-103 | In distribution | |
| 19222-201 | In distribution | |
| 10800 | In distribution | |
| 29698-001 | In distribution | |
| 26618-001 | In distribution | |
| 29657-001 | In distribution | |
| 29660-001 | In distribution | |
| 14859-001 | In distribution | |
| 10130 | In distribution | |
| 19102-001 | In distribution | |
| 24555-001 | In distribution | |
| 10819×10 | In distribution | |
| 18172-001 | In distribution | |
| 19103-001 | In distribution | |
| 18221-101 | In distribution | |
| 29658-001 | In distribution | |
| 29695-001 | In distribution | |
| 11872×10 | In distribution | |
| 10818×10 | In distribution | |
| 18929-001 | In distribution | |
| 29700-001 | In distribution | |
| 11450 | In distribution | |
| 19333-201 | In distribution | |
| 19189-001 | In distribution | |
| 29715-001 | In distribution | |
| 15091-103 | In distribution | |
| 29702-001 | In distribution | |
| 29660-001 | In distribution | |
| 10821×10 | In distribution | |
| 15091-104 | In distribution | |
| 29710-001 | In distribution | |
| 15090-102 | In distribution | |
| 11454 | In distribution | |
| 29663-001 | In distribution | |
| 11505×10 | In distribution | |
| 10611 | In distribution | |
| 11581-G | In distribution | |
| 10700 | In distribution | |
| 10822×10 | In distribution | |
| 29665-001 | In distribution | |
| 10696 | In distribution | |
| 10823×10 | In distribution | |
| 19096-001 | In distribution | |
| 14982-001 | In distribution | |
| 15090-101 | In distribution | |
| 29701-001 | In distribution | |
| 10611 | In distribution | |
| 22770-001 | In distribution | |
| 10696 | In distribution | |
| 15091-102 | In distribution | |
| 11558×10 | In distribution | |
| 29697-001 | In distribution | |
| 29659-001 | In distribution | |
| 18093-001 | In distribution | |
| 14858-001 | In distribution | |
| 29696-001 | In distribution | |
| 17527-001 | In distribution | |
| 11451 | In distribution | |
| 15091-101 | In distribution | |
| 11872×10 | In distribution | |
| 11452 | In distribution | |
| 18888-001 | In distribution | |
| 17650-001 | In distribution | |
| 10820×10 | In distribution | |
| 29662-001 | In distribution | |
| 11455 | In distribution | |
| 11453 | In distribution | |
| 19444-001 | In distribution | |
| 10694 | In distribution | |
| 17475-001 | In distribution | |
| 11475 | In distribution | |
| 18941-001 | In distribution | |
| 29703-001 | In distribution | |
| 18930-001 | In distribution | |
| 21102-001 | In distribution | |
| 15091-102 | Withdrawn | |
| 29658-001 | Withdrawn | |
| 15090-104 | Withdrawn | |
| 29665-001 | Withdrawn | |
| 14858-001 | Withdrawn | |
| 14859-001 | Withdrawn | |
| 15091-104 | Withdrawn | |
| 29659-001 | Withdrawn | |
| 29662-001 | Withdrawn | |
| 15090-102 | Withdrawn | |
| 29663-001 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Puritan Bennett | Covidien LP | 285 |
| Newport | Newport Medical Instruments, Inc. | 103 |
| Ventilator, Continuous, Facility Use | Hans Rudolph, Inc. | 66 |
| Infant Flow SiPAP | Carefusion | 62 |
| Avea | Carefusion | 57 |
| Ventoux | Flight Medical Innovations Ltd. | 48 |
| Trilogy | Respironics Inc. | 42 |
| Avea™ | Vyaire Medical, Inc. | 39 |
| Patient Circuits | Zoll Medical Corporation | 38 |
| Performatrak | Respironics Inc. | 35 |
| Bio-Med Devices, Inc. | BIO-MED Devices, Inc. | 34 |
| Vent | Zoll Medical Corporation | 32 |
Showing 12 of 419. All products under Ventilator, Continuous, Facility Use
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201082 | 2021-11-10 |
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-05-05 | Class II | Nonconforming Material/Component | Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use, the touchscreen may become unresponsive and the device application stops responding (APP Hang | 910 units | |
| 2023-05-05 | Class II | Nonconforming Material/Component | Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use, the touchscreen may become unresponsive and the device application stops responding (APP Hang | 392 units | |
| 2021-12-20 | Class I | Software change control | Potential cessation in ventilation can occur under specific conditions. | 4189 units | 2024-08-28 |
| 2019-11-25 | Class II | Software design | The G6 bellavista 1000 US ventilators may experience intermittent failures: Lack of acoustic high priority alarm, presence of a ‘no alarm’ condition, or presence of non-responsive touch screen. | 116 | 2023-08-08 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.