Entuit
Entuit Gastrostomy Set with ENFit Connection
1manufacturer
8catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Texnet | Suzhou | Jiangsu | Contract manufacturer | 47 |
Record
| Listed by | Cook Incorporated, United States |
|---|---|
| FDA product code | PRR |
| Device type | Feeding Tube Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5980 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-08-21 |
| Record revised | 2022-06-10 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in dark, dry, cool place. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G47284 | In distribution | |
| G47289 | In distribution | |
| G47287 | In distribution | |
| G47288 | In distribution | |
| G47285 | In distribution | |
| G47290 | In distribution | |
| G47291 | In distribution | |
| G47286 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 2 |
| Medline | Medline Industries, Inc. | 2 |
| Centurion | Centurion Medical Products Corporation | 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.