Endolumik
Endolumik Gastric Calibration Tube, 40F
3manufacturers in China registered for this device type
1catalogue number
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 | Endolumik, United States |
|---|---|
| FDA product code | FAT |
| Device type | Bougie, Esophageal, And Gastrointestinal, Gastro-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5365 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2023-05-15 |
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 |
| Storage | Storage environment atmospheric pressure 500 to 1060 KiloPascal; Storage environment humidity 0 to 90 % RH; Storage environment temperature 0 to 140 °F |
| Packaging | Cardboard box of 5 |
| Sizes | Circumference 41.9 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EGCT40 | Circumference 41.9 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pilling | Teleflex Medical LLC | 128 |
| WeightRight® | Diversatek Healthcare Inc | 50 |
| M-Flex® | Diversatek Healthcare Inc | 46 |
| Aspen® Flexible Light Handle Cover | Aspen Surgical Products, Inc. | 3 |
| 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.