Bio-Med Devices, Inc.
Infant Ventilator, pneumatic, MR-conditional, with blender and flowmeter
8manufacturers in China registered for this device type
34catalogue numbers in this listing
9510(k) clearances naming this product code
10recalls 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 | BIO-MED Devices, Inc., United States |
|---|---|
| FDA product code | CBK |
| Device type | Ventilator, Continuous, Facility Use |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5895 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K942938 |
| Record published | 2015-11-02 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CROSSVENT | In distribution | |
| CROSSVENT | In distribution | |
| MVP-10 | In distribution | |
| CROSSVENT | In distribution | |
| CROSSVENT | In distribution | |
| CROSSVENT | In distribution | |
| CROSSVENT | In distribution | |
| CROSSVENT | In distribution | |
| CROSSVENT | In distribution | |
| CROSSVENT | In distribution | |
| IC-2A | In distribution | |
| CROSSVENT | In distribution | |
| CROSSVENT | In distribution | |
| CROSSVENT | In distribution | |
| MVP-10 | In distribution | |
| CROSSVENT | In distribution | |
| CROSSVENT | In distribution | |
| MVP-10 | In distribution | |
| MVP-10 | In distribution | |
| CROSSVENT | In distribution | |
| MVP-10 | In distribution | |
| CROSSVENT | In distribution | |
| CROSSVENT | In distribution | |
| IC-2A | In distribution | |
| TV-100 | In distribution | |
| IC-2A | In distribution | |
| MVP-10 | In distribution | |
| CROSSVENT | In distribution | |
| CROSSVENT | In distribution | |
| CROSSVENT | In distribution | |
| CROSSVENT | In distribution | |
| MVP-10 | In distribution | |
| CROSSVENT | In distribution | |
| MVP-10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Puritan Bennett | Covidien LP | 285 |
| Newport | Newport Medical Instruments, Inc. | 103 |
| LTV | Vyaire Medical, Inc. | 92 |
| 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 |
| Vent | Zoll Medical Corporation | 32 |
Showing 12 of 419. All products under Ventilator, Continuous, Facility Use
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K173973 | 2018-07-20 |
| K942938 | 1995-09-19 |
| K896381 | 1990-02-12 |
| K896380 | 1990-02-12 |
| K830230 | 1983-02-09 |
| K823861 | 1983-02-07 |
| K813253 | 1981-12-09 |
| K801890 | 1980-11-18 |
| K800125 | 1980-01-24 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2010-10-19 | Not classified | Component change control | Breathing circuit may disconnect between the adapter adjacent tubing cuff | 15 cases (20/cs) | 2014-10-23 |
| 2010-10-19 | Not classified | Component change control | Breathing circuit may disconnect between the adapter adjacent tubing cuff | 1 case (20/cs) | 2014-10-23 |
| 2004-12-06 | Not classified | Other | Adapters may be occluded potentially preventing inhalation | 58 cs | 2005-11-21 |
| 2004-12-06 | Not classified | Other | Adapters may be occluded potentially preventing inhalation | 107 cs | 2005-11-21 |
| 2004-12-06 | Not classified | Other | Adapters may be occluded potentially preventing inhalation | 4 cs | 2005-11-21 |
| 2004-12-06 | Not classified | Other | Adapters may be occluded potentially preventing inhalation | 159 cs | 2005-11-21 |
| 2004-12-06 | Not classified | Other | Adapters may be occluded potentially preventing inhalation | 159 cs | 2005-11-21 |
| 2004-12-06 | Not classified | Other | Adapters may be occluded potentially preventing inhalation | 71 cs | 2005-11-21 |
| 2004-12-06 | Not classified | Other | Adapters may be occluded potentially preventing inhalation | 2 cs | 2005-11-21 |
| 2004-12-06 | Not classified | Other | Adapters may be occluded potentially preventing inhalation | 111 cs | 2005-11-21 |
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.