Neo-Vent™
Infant T-Piece Resuscitation Circuit w/ Infant Neonate Masks
9manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
3recalls on this code
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 | Westmed, Inc., 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, Remanufacturer, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K923618 |
| Record published | 2017-10-27 |
| Record revised | 2023-09-29 (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 |
| Packaging | Pack of 10 |
| Distribution end date | 2023-09-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0419 | Withdrawn |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 |
| Flow-Safe Disposable CPAP System | Mercury Medical Enterprises, LLC | 29 |
| 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 |
Showing 12 of 139. All products under Attachment, Breathing, Positive End Expiratory Pressure
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K955047 | 1996-03-27 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Westmed, Inc. | 510(k) number | 2019-01-15 | Class II | Device Design | A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and non-compliant 15mm OD connections. This resulted in facilities with infant resuscitators that connect via the 15mm OD fitting not | 625 cases | 2021-02-05 |
| Westmed, Inc. | 510(k) number | 2019-01-15 | Class II | Device Design | A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and non-compliant 15mm OD connections. This resulted in facilities with infant resuscitators that connect via the 15mm OD fitting not | 35 cases | 2021-02-05 |
| Westmed, Inc. | 510(k) number | 2019-01-15 | Class II | Device Design | A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and non-compliant 15mm OD connections. This resulted in facilities with infant resuscitators that connect via the 15mm OD fitting not | 48 cases | 2021-02-05 |
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.