Reusable Conventional Blade American Mac 2
Catalogue number 040-192U, listed by Flexicare Medical Ltd., United Kingdom, under Laryngoscope, Rigid. 44 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Guangdong (22), Jiangsu (9), Zhejiang (7). 8 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 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Ambu Limited | Xiang Yu F.T.Z., Xiamen | Fujian | Contract manufacturer | 11 |
| Shenzhen Insighters Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Dongguan Honfield Precision Parts Co., Ltd. | Zhangmutou, Dongguan | Guangdong | Contract manufacturer | 8 |
| MediConcepts Technology (Shenzhen) Company Limited | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Saferlife Products Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 58 |
Showing 12 of 44. All 44 manufacturers in China registered for Laryngoscope, Rigid
Record
| Listed by | Flexicare Medical Ltd., United Kingdom |
|---|---|
| FDA product code | CCW |
| Device type | Laryngoscope, Rigid |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5540 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-04-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 040-192U | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rusch | Teleflex Medical LLC | 509 |
| SunMed | SunMed Group Holdings, LLC | 255 |
| Ambler Surgical | Ambler Surgical, LLC | 192 |
| AincA® | Anesthesia Associates, Inc. | 186 |
| Curaplex | Bound Tree Medical, LLC | 172 |
| GlideScope® | Verathon Medical (Canada) ULC | 166 |
| Pilling | Teleflex Medical LLC | 163 |
| Carnegie Surgical LLC | Carnegie Surgical LLC | 157 |
| Laryngoscope, Rigid | Karl Storz GmbH & Co. KG | 140 |
| Medline | Medline Industries, Inc. | 128 |
| Millennium | Avalign Technologies, Inc. | 111 |
| Sklar® | Sklar Corporation | 92 |
Showing 12 of 442. All products under Laryngoscope, Rigid
Recalls
2 of these are Class II. 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 |
|---|---|---|---|---|---|
| 2019-11-27 | Class II | Nonconforming Material/Component | The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. If the blade is disengage over the patient’s mount it is a possibility that any loos | 1,024,890 devices | 2021-04-27 |
| 2019-11-27 | Class II | Nonconforming Material/Component | The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. If the blade is disengage over the patient’s mount it is a possibility that any loos | 1,024,890 devices | 2021-04-27 |
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.