Hospitak, Mouth to Mask Resuscitator Adult Medium Mask
Catalogue number 1058-E, listed by Convatec, Purchasing Department, under Ventilator, Emergency, Manual (Resuscitator). 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Fujian (4), Zhejiang (1), Guangdong (1). 5 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 |
| Polymed (Xiamen) Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 17 |
| VR Medical Technology Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 13 |
| Ambu Limited | Xiang Yu F.T.Z., Xiamen | Fujian | Contract manufacturer | 11 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Laerdal Medical (Suzhou) Co., Ltd. | 215009 Suzhou Jiangsu Province | Repacker / relabeller | 12 | |
| Xiamen Compower Medical Tech. Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 9 |
Record
| Listed by | Convatec, Purchasing Department |
|---|---|
| FDA product code | BTM |
| Device type | Ventilator, Emergency, Manual (Resuscitator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5915 |
| 510(k) | K873286 |
| Record published | 2015-10-15 |
| Record revised | 2022-05-23 (version 5) |
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 20 |
| Distribution end date | 2022-05-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1058-E | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ventlab | Ventlab, LLC | 405 |
| CPR-2 Bag | Mercury Medical Enterprises, LLC | 231 |
| CPR Bag | Mercury Medical Enterprises, LLC | 187 |
| Vital Signs™ | Airlife, Inc. | 102 |
| Medline | Medline Industries, Inc. | 78 |
| Spur® II Pediatric ResuscitatorSingle Patient Use Resuscitator | Ambu A/S | 74 |
| Spur® II Adult ResuscitatorSingle Patient Use Resuscitator | Ambu A/S | 66 |
| Hudson RCI | Teleflex Medical LLC | 56 |
| Medline Industries, Inc. | Medline Industries, Inc. | 53 |
| Portex | ICU Medical, Inc | 45 |
| Spur® II Infant ResuscitatorSingle Patient Use Resuscitator | Ambu A/S | 45 |
| Curaplex® | Bound Tree Medical, LLC | 38 |
Showing 12 of 342. All products under Ventilator, Emergency, Manual (Resuscitator)
Recalls Naming This Product
23 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 |
|---|---|---|---|---|---|---|---|
| Unomedical | 510(k) number | 2009-10-06 | Not classified | Device Design | In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pr | over 200 total lots | 2010-08-10 |
| Unomedical | 510(k) number | 2009-10-06 | Not classified | Device Design | In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pr | over 200 total lots | 2010-08-10 |
| Unomedical | 510(k) number | 2009-10-06 | Not classified | Device Design | In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pr | over 200 lots | 2010-08-10 |
| Unomedical | 510(k) number | 2009-10-06 | Not classified | Device Design | In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pr | over 200 total lots | 2010-08-10 |
| Unomedical | 510(k) number | 2009-10-06 | Not classified | Device Design | In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pr | over 200 total lots | 2010-08-10 |
| Unomedical | 510(k) number | 2009-10-06 | Not classified | Device Design | In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pr | over 200 total lots | 2010-08-10 |
| Unomedical | 510(k) number | 2009-10-06 | Not classified | Device Design | In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pr | over 200 total lots | 2010-08-10 |
| Unomedical | 510(k) number | 2009-10-06 | Not classified | Device Design | In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pr | over 200 total lots | 2010-08-10 |
| Unomedical | 510(k) number | 2009-10-06 | Not classified | Device Design | In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pr | over 200 total lots | 2010-08-10 |
| Unomedical | 510(k) number | 2009-10-06 | Not classified | Device Design | In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pr | over 200 total lots | 2010-08-10 |
| Unomedical | 510(k) number | 2009-10-06 | Not classified | Device Design | In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pr | over 200 total lots | 2010-08-10 |
| Unomedical | 510(k) number | 2009-10-06 | Not classified | Device Design | In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pr | over 200 total lots | 2010-08-10 |
| Unomedical | 510(k) number | 2009-10-06 | Not classified | Device Design | In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pr | over 200 total lots | 2010-08-10 |
| Unomedical | 510(k) number | 2009-10-06 | Not classified | Device Design | In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pr | over 200 total lots | 2010-08-10 |
| Unomedical | 510(k) number | 2009-10-06 | Not classified | Device Design | In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pr | over 200 total lots | 2010-08-10 |
| Unomedical | 510(k) number | 2009-10-06 | Not classified | Device Design | In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pr | over 200 total lots | 2010-08-10 |
| Unomedical | 510(k) number | 2009-10-06 | Not classified | Device Design | In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pr | over 200 total lots | 2010-08-10 |
| Unomedical | 510(k) number | 2009-10-06 | Not classified | Device Design | In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pr | over 200 total lots | 2010-08-10 |
| Unomedical | 510(k) number | 2009-10-06 | Not classified | Device Design | In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pr | over 200 total lots | 2010-08-10 |
| Unomedical | 510(k) number | 2009-10-06 | Not classified | Device Design | In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pr | over 200 total lots. | 2010-08-10 |
| Unomedical | 510(k) number | 2009-10-06 | Not classified | Device Design | In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pr | over 200 total lots | 2010-08-10 |
| Unomedical | 510(k) number | 2009-10-06 | Not classified | Device Design | In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pr | over 200 total lots | 2010-08-10 |
| Unomedical | 510(k) number | 2009-10-06 | Not classified | Device Design | In some Manual Pulmonary Resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the MPR bag/body. If this occurs, the MPR may lose its ability to generate the positive pr | over 200 lots | 2010-08-10 |
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.