SaftiCuff DK
Safticuff DL Airway
6manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Bracco Diagnostics, 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 | 2016-09-19 |
| Record revised | 2025-05-26 (version 6) |
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 |
| Packaging | Box of 75, pack of 75 |
| Sizes | Catheter gauge 48 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 900910 | Catheter Gauge 48 Fr | In distribution |
| 900910 | Catheter Gauge 48 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.