M-Flex®
Blue Silicone Tungsten Maloney Esophageal Dilator, 24 French
3manufacturers in China registered for this device type
46catalogue numbers in this listing
Who Else Makes It
All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Jiuhong Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 20 |
| Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 14 |
Record
| Listed by | Diversatek Healthcare Inc, United States |
|---|---|
| FDA product code | FAT |
| Device type | Bougie, Esophageal, And Gastrointestinal, Gastro-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5365 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-17 |
| Record revised | 2019-04-10 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization, High-level Disinfectant |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store flat, do not hang |
| Sizes | Catheter gauge 20 to 60 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1206-24 | Catheter Gauge 24 Fr | In distribution |
| 1207-32 | Catheter Gauge 32 Fr | In distribution |
| 1207-10 | In distribution | |
| 1206-42 | Catheter Gauge 42 Fr | In distribution |
| 1206-10 | In distribution | |
| 1206-34 | Catheter Gauge 34 Fr | In distribution |
| 1207-42 | Catheter Gauge 42 Fr | In distribution |
| 1206-20 | Catheter Gauge 20 Fr | In distribution |
| 1207-22 | Catheter Gauge 22 Fr | In distribution |
| 1206-52 | Catheter Gauge 52 Fr | In distribution |
| 1206-36 | Catheter Gauge 36 Fr | In distribution |
| 1206-44 | Catheter Gauge 44 Fr | In distribution |
| 1206-58 | Catheter Gauge 58 Fr | In distribution |
| 1207-38 | Catheter Gauge 38 Fr | In distribution |
| 1207-50 | Catheter Gauge 50 Fr | In distribution |
| 1206-54 | Catheter Gauge 54 Fr | In distribution |
| 1206-50 | Catheter Gauge 50 Fr | In distribution |
| 1207-56 | Catheter Gauge 56 Fr | In distribution |
| 1207-48 | Catheter Gauge 48 Fr | In distribution |
| 1207-36 | Catheter Gauge 36 Fr | In distribution |
| 1207-60 | Catheter Gauge 60 Fr | In distribution |
| 1206-46 | Catheter Gauge 46 Fr | In distribution |
| 1206-30 | Catheter Gauge 30 Fr | In distribution |
| 1206-60 | Catheter Gauge 60 Fr | In distribution |
| 1206-40 | Catheter Gauge 40 Fr | In distribution |
| 1207-26 | Catheter Gauge 26 Fr | In distribution |
| 1207-00 | In distribution | |
| 1206-26 | Catheter Gauge 26 Fr | In distribution |
| 1207-28 | Catheter Gauge 28 Fr | In distribution |
| 1207-30 | Catheter Gauge 30 Fr | In distribution |
| 1206-32 | Catheter Gauge 32 Fr | In distribution |
| 1207-54 | Catheter Gauge 54 Fr | In distribution |
| 1207-46 | Catheter Gauge 46 Fr | In distribution |
| 1206-48 | Catheter Gauge 48 Fr | In distribution |
| 1207-52 | Catheter Gauge 52 Fr | In distribution |
| 1207-58 | Catheter Gauge 58 Fr | In distribution |
| 1207-44 | Catheter Gauge 44 Fr | In distribution |
| 1206-22 | Catheter Gauge 22 Fr | In distribution |
| 1206-38 | Catheter Gauge 38 Fr | In distribution |
| 1207-34 | Catheter Gauge 34 Fr | In distribution |
| 1206-00 | In distribution | |
| 1206-56 | Catheter Gauge 56 Fr | In distribution |
| 1207-40 | Catheter Gauge 40 Fr | In distribution |
| 1207-24 | Catheter Gauge 24 Fr | In distribution |
| 1207-20 | Catheter Gauge 20 Fr | In distribution |
| 1206-28 | Catheter Gauge 28 Fr | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pilling | Teleflex Medical LLC | 128 |
| WeightRight® | Diversatek Healthcare Inc | 50 |
| Aspen® Flexible Light Handle Cover | Aspen Surgical Products, Inc. | 3 |
| Endolumik | Endolumik | 1 |
| Aspen® Flexible Light Handle Adapter | Aspen Surgical Products, Inc. | 1 |
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.