iCOR
FH With Soft - Flex AND Swivel
29manufacturers in China registered for this device type
23catalogue numbers in this listing
5recalls on this code
Who Else Makes It
Concentrated in Zhejiang (10), Guangdong (8), Jiangsu (5). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Amsino Medical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 22 |
| Zhejiang Haisheng Medical Device Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 21 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
| IPE Plastic & Hardware Industy, Ltd | Dongguan | Guangdong | Contract manufacturer | 15 |
| VR Medical Technology Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 13 |
| Zhejiang Runqiang Medical Instruments Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 9 |
| Ningbo Boya Medical Equipment Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 8 |
| GVS Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
Showing 12 of 29. All 29 manufacturers in China registered for Condenser, Heat And Moisture (Artificial Nose)
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | BYD |
| Device type | Condenser, Heat And Moisture (Artificial Nose) |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5375 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K925622 |
| Record published | 2016-09-16 |
| Record revised | 2020-09-22 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 24, box of 25, box of 30, box of 15, box of 10, box of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN040577 | In distribution | |
| IPN040598 | In distribution | |
| IPN040597 | In distribution | |
| IPN040483 | In distribution | |
| IPN040455 | In distribution | |
| IPN040509 | In distribution | |
| IPN040596 | In distribution | |
| IPN040559 | In distribution | |
| IPN040517 | In distribution | |
| IPN040563 | In distribution | |
| IPN040551 | In distribution | |
| IPN040515 | In distribution | |
| IPN040460 | In distribution | |
| IPN040537 | In distribution | |
| IPN040527 | In distribution | |
| IPN040503 | In distribution | |
| IPN040498 | In distribution | |
| IPN040584 | In distribution | |
| IPN040475 | In distribution | |
| IPN040571 | In distribution | |
| IPN040486 | In distribution | |
| IPN040471 | In distribution | |
| IPN040523 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Portex | ICU Medical, Inc | 34 |
| Hudson RCI | Teleflex Medical LLC | 34 |
| Gibeck | Teleflex Medical LLC | 27 |
| DAR | Covidien LP | 21 |
| AirLife™ | Airlife, Inc. | 20 |
| Medisize® | Medisize B.V. | 19 |
| AirLife™ | Vyaire Medical, Inc. | 13 |
| HME | Pepper Medical, Inc. | 11 |
| ThermoFlo® | Typenex Medical, LLC | 11 |
| InHealth Technologies; Blom-Singer | Freudenberg Medical, LLC | 11 |
| Heat Moisture Exchanger | Sunset Healthcare Solutions, Inc. | 9 |
| Closed Suction System | VR Medical Technology Co., Ltd. | 7 |
Showing 12 of 219. All products under Condenser, Heat And Moisture (Artificial Nose)
Recalls
2 of these are 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 |
|---|---|---|---|---|---|
| 2022-04-11 | Class II | Device Design | Reports received of torn corrugated breathing tubes. | 59,581 eaches | |
| 2015-12-03 | Class II | Device Design | Cracking may occur at the 15mm and 22mm ISO female connector. | 2,700 units | 2017-01-24 |
| 2015-12-03 | Class II | Release of Material/Component prior to receiving test results | Cracks may occur at the 15mm and 22mm ISO female connector. | 2,700 ea. | 2017-04-14 |
| 2015-01-12 | Class I | Process control | Defects: Cracks that may occur in the center of the corrugated flex tube of the 15 mm and 22 mm ISO female connector. | 100 units | 2016-05-10 |
| 2014-12-04 | Class I | Process control | Connector mount cracks which may lead to a leak failure during use and necessitate immediate replacement in the breathing circuit. If leak exists and is left untreated, patient may be deprived of adequate anesthetic gases over a period of | 18 | 2017-03-21 |
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.