Medline
TUBE,RECTAL,POLY-CATH,18FR,NON-STER,
6manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (3). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| Suzhou Texnet | Suzhou | Jiangsu | Contract manufacturer | 47 |
| Wenzhou Zuoyou Medical Technoloyg Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 21 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | FGD |
| Device type | Catheter, Retention, Barium Enema With Bag |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5980 |
| Premarket notification | Exempt |
| Record published | 2021-01-05 |
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 |
| Packaging | Case of 10 |
| Sizes | Catheter gauge 18 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYND70110 | Catheter Gauge 18 Fr | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Enema Kit: Empty Enema Bag Delivery System | Bracco Diagnostics, Inc. | 5 |
| Flexi-Stome Cone Colostomy Tip | Bracco Diagnostics, Inc. | 3 |
| Tubing Clamp: Fits Standard 5/16′ Tubing | Bracco Diagnostics, Inc. | 2 |
| Rounded Flexi Tip Adult Enema Tip | Bracco Diagnostics, Inc. | 2 |
| 24 Fr Infant Flexi Tip: Pediatric Enema Tip | Bracco Diagnostics, Inc. | 2 |
| Enema Ring: Fluid Collection Device | Bracco Diagnostics, Inc. | 2 |
| Blue Air Bulb Insufflator | Bracco Diagnostics, Inc. | 2 |
| Super XL Enema System | Bracco Diagnostics, Inc. | 2 |
| Junior Flexi Tip Pediatric Enema Tip | Bracco Diagnostics, Inc. | 2 |
| 18 French Pediatric Flexi Tip | Bracco Diagnostics, Inc. | 2 |
| Retention Cuff Inflator | Bracco Diagnostics, Inc. | 2 |
| Safti Cuff | Bracco Diagnostics, Inc. | 2 |
Showing 12 of 26. All products under Catheter, Retention, Barium Enema With Bag
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.