Flow-Safe Disposable CPAP System
29 catalogue numbers from 10-57002, listed by Mercury Medical Enterprises, LLC, United States, under Attachment, Breathing, Positive End Expiratory Pressure. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
29catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (5), Fujian (3), elsewhere (1). 7 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 |
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Polymed (Xiamen) Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 17 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
| Ambu Limited | Xiang Yu F.T.Z., Xiamen | Fujian | Contract manufacturer | 11 |
| Flying Tooling Engineering Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| Laerdal Medical (Suzhou) Co., Ltd. | 215009 Suzhou Jiangsu Province | Repacker / relabeller | 12 | |
| Shenzhen Wellcore Well Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
Record
| Listed by | Mercury Medical Enterprises, LLC, United States |
|---|---|
| FDA product code | BYE |
| Device type | Attachment, Breathing, Positive End Expiratory Pressure |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5965 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K090710 |
| Record published | 2015-09-24 |
| Record revised | 2019-12-31 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 5, pack of 2 |
| Distribution end date | 2019-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10-57002 | In distribution | |
| 10-57001 | In distribution | |
| 10-57012 | In distribution | |
| 10-57019 | In distribution | |
| 10-57022 | In distribution | |
| 10-57003 | In distribution | |
| 10-57018 | In distribution | |
| 10-57009 | In distribution | |
| 10-57021 | In distribution | |
| 10-57008 | In distribution | |
| 10-57036 | In distribution | |
| 10-57000 | In distribution | |
| 10-57031 | In distribution | |
| 10-57032 | In distribution | |
| 10-57011 | In distribution | |
| 10-57007 | In distribution | |
| 10-57035 | In distribution | |
| 10-57037 | In distribution | |
| 10-57020 | In distribution | |
| 10-57010 | In distribution | |
| 10-57023 | In distribution | |
| 10-57034 | In distribution | |
| 10-57033 | In distribution | |
| 10-57006 | In distribution | |
| 10-57013 | Withdrawn | |
| 10-57015 | Withdrawn | |
| 10-57017 | Withdrawn | |
| 10-57016 | Withdrawn | |
| 10-57014 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| O2-MAX | Pulmodyne Inc. | 136 |
| 02-MAX | Pulmodyne Inc. | 83 |
| 02-RESQ | Pulmodyne Inc. | 43 |
| Flow-Safe II Disposable CPAP System | Mercury Medical Enterprises, LLC | 36 |
| Curaplex® | Bound Tree Medical, LLC | 31 |
| AincA | Anesthesia Associates, Inc. | 30 |
| Attachment, Breathing, Positive End Expiratory Pressure | Galemed Corp. | 25 |
| Shiley | Covidien LP | 21 |
| Infant Resuscitation Kit. T-Piece Circuit | Flexicare Medical Ltd. | 20 |
| AirLife | Carefusion | 17 |
| O2-RESQ | Pulmodyne Inc. | 17 |
| Go-PAP | Pulmodyne Inc. | 14 |
Showing 12 of 139. All products under Attachment, Breathing, Positive End Expiratory Pressure
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.