Corflo Ultra Lite NG
Feeding tube, non weighted, without stylet and with Anti-IV connector
3manufacturers in China registered for this device type
13catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (1), Zhejiang (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| ShanDong WeiGao Group Medical Polymer Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
| VR Medical Technology Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 13 |
| Ningbo Tianyi Medical Appliance Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 11 |
Record
| Listed by | Corpak Medsystems, United States |
|---|---|
| FDA product code | FPD |
| Device type | Tube, Feeding |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5980 |
| Record published | 2016-08-04 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 10 |
| Sizes | Catheter gauge 5 to 12 Fr; length 15 to 43 in |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20-1432AIV2 | Catheter Gauge 12 Fr | In distribution |
| 20-1361AIV2 | Length 36 in | In distribution |
| 20-1431AIV2 | Catheter Gauge 10 Fr | In distribution |
| 20-1365AIV2 | Catheter Gauge 5 Fr | In distribution |
| 20-1226AIV2 | 6FR (2mm) X 22″ (56cm) | In distribution |
| 20-1368AIV2 | Length 36 in | In distribution |
| 20-1366AIV2 | 6FR (2mm) X 36″ (91cm) | In distribution |
| 20-1362AIV2 | Catheter Gauge 12 Fr | In distribution |
| 20-9361AIV2 | Length 36 in | In distribution |
| 20-1438AIV2 | 8 FR (2.7mm) X 43″ (109cm) | In distribution |
| 20-9368AIV2 | 8FR (2.7mm) X 36″ (91 cm) | In distribution |
| 20-1155AIV2 | Catheter Gauge 5 Fr | In distribution |
| 20-1156AIV2 | Length 15 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vygon | Vygon Corp. | 236 |
| Ameritus | Kentec Medical, LLC | 83 |
| Avanos | Avanos Medical, Inc. | 51 |
| Halyard | Avanos Medical, Inc. | 50 |
| Ameritus ENFit | Kentec Medical, LLC | 38 |
| MED-RX | Canadian Hospital Specialties Ltd. | 28 |
| DeRoyal | Deroyal Industries, Inc. | 20 |
| ENFit SIL Feeding Tube | Avanos Medical, Inc. | 18 |
| NeoConnect Enteral Feeding Tube | Neomed Co., Ltd. | 18 |
| TubeClear | Actuated Medical, Inc. | 14 |
| Aquarius | Degania Silicone, Ltd. | 11 |
| NeoMed Enteral Feeding Tube | Neomed Co., Ltd. | 11 |
Showing 12 of 33. All products under Tube, Feeding
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K083776 | 2009-03-05 |
| K083791 | 2009-03-04 |
| K083786 | 2009-02-20 |
| K083210 | 2008-12-29 |
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.