Stat-Check
Stat-Check Adult Resuscitator with Inflatable Bag Reservoir, PEEP Valve + Adapter, Mask & MaxCap
8manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
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 | Ventlab, LLC, United States |
|---|---|
| FDA product code | BTM |
| Device type | Ventilator, Emergency, Manual (Resuscitator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5915 |
| 510(k) | K982215 |
| Record published | 2019-12-17 |
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 |
| Storage | Special storage condition: Store at room temperature. Do not get wet. |
| Packaging | Box of 10 |
| Sizes | Total volume 250 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SC9200MBP-X | Total Volume 250 ml | In distribution |
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)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K012842 | 2001-09-18 |
| K913900 | 1992-01-07 |
Recalls Naming This Product
7 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 |
|---|---|---|---|---|---|---|---|
| SunMed Group Holdings, LLC | 510(k) number | 2014-05-16 | Class I | Process change control | The pop-off valve in the defective devices remain open and a squeeze of the bag may not generate enough force to force the duck bill valve open and therefore no air will be delivered to the victim. | 251,384 | 2015-11-17 |
| SunMed Group Holdings, LLC | 510(k) number | 2012-07-11 | Class I | Component design/selection | Possible volume leakage through the inlet valve during compressions of the resuscitator bag. | 14,602 total for all units | 2013-06-30 |
| SunMed Group Holdings, LLC | 510(k) number | 2004-03-26 | Not classified | Other | In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure. | 3070 units | 2004-07-07 |
| SunMed Group Holdings, LLC | 510(k) number | 2004-03-26 | Not classified | Other | In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure. | 520 units | 2004-07-07 |
| SunMed Group Holdings, LLC | 510(k) number | 2004-03-26 | Not classified | Other | In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure. | 18460 units | 2004-07-07 |
| SunMed Group Holdings, LLC | 510(k) number | 2004-03-26 | Not classified | Other | In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure. | 10 units | 2004-07-07 |
| SunMed Group Holdings, LLC | 510(k) number | 2004-03-26 | Not classified | Other | In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure. | 60 units | 2004-07-07 |
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.