Corflo cuBBy Lpgd
Low profile gastrostomy device kit with ENFit Connectors
25manufacturers in China registered for this device type
98catalogue numbers in this listing
9510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (17), Zhejiang (4), Guangdong (2). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 18 |
| Mcreat ( Guangzhou ) BIO-Tech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 14 |
| Primecare Medical (Huzhou) Co., Ltd. | Hu Zhou | Zhejiang | Contract manufacturer | 9 |
| Yangzhou Xingwei Medical Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 5 |
| Tessy Plastics Shanghai Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| Flexan (Suzhou) Precision Rubber Products Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 1 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
Showing 12 of 25. All 25 manufacturers in China registered for Tubes, Gastrointestinal (And Accessories)
Record
| Listed by | Corpak Medsystems, United States |
|---|---|
| FDA product code | KNT |
| Device type | Tubes, Gastrointestinal (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5980 |
| Record published | 2016-06-24 |
| Record revised | 2019-10-07 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: No |
| Sizes | Catheter gauge 12 to 24 Fr; length 1 to 6.5 cm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 55-2020 | Catheter Gauge 20 Fr | In distribution |
| 35-1415 | 14 FR (4.7mm) X 1.5cm | In distribution |
| 55-1640 | Catheter Gauge 16 Fr | In distribution |
| 35-1840 | Length 4 cm | In distribution |
| 35-2010 | Catheter Gauge 20 Fr | In distribution |
| 55-1250 | 12 FR (4mm) x 5.0cm | In distribution |
| 55-1820 | Catheter Gauge 18 Fr | In distribution |
| 35-1810 | 18 FR (6mm) X 1.0cm | In distribution |
| 55-1825 | Length 2.5 cm | In distribution |
| 35-2035 | Catheter Gauge 20 Fr | In distribution |
| 35-1235 | Length 3.5 cm | In distribution |
| 35-1430 | 14 FR (4.7mm) X 3.0cm | In distribution |
| 55-2025 | 20 FR (6.7mm) x 2.5cm | In distribution |
| 55-1430 | 14 FR (4.7mm) x 3.0cm | In distribution |
| 35-1815 | Length 1.5 cm | In distribution |
| 35-2445 | Catheter Gauge 24 Fr | In distribution |
| 55-1410 | 14 FR (4.7mm) x 1.0cm | In distribution |
| 35-1230 | Catheter Gauge 12 Fr | In distribution |
| 55-1815 | 18FR (6mm) x 1.5cm | In distribution |
| 35-1620 | 16 FR (5.3mm) X 2.0cm | In distribution |
| 55-1255 | Catheter Gauge 12 Fr | In distribution |
| 35-1640 | Catheter Gauge 16 Fr | In distribution |
| 55-2015 | Length 1.5 cm | In distribution |
| 55-1260 | Catheter Gauge 12 Fr | In distribution |
| 55-1235 | Catheter Gauge 12 Fr | In distribution |
| 55-1625 | Length 2.5 cm | In distribution |
| 35-1610 | Length 1 cm | In distribution |
| 55-2445 | Catheter Gauge 24 Fr | In distribution |
| 55-1610 | 16 FR (5.3mm) x 1.0cm | In distribution |
| 35-1410 | Catheter Gauge 14 Fr | In distribution |
| 55-2010 | Length 1 cm | In distribution |
| 35-2435 | Catheter Gauge 24 Fr | In distribution |
| 35-2440 | 24 FR (8mm) X 4.0cm | In distribution |
| 55-2040 | 20 FR (6.7mm) x 4.0cm | In distribution |
| 55-2410 | Length 1 cm | In distribution |
| 55-2035 | Catheter Gauge 20 Fr | In distribution |
| 55-1435 | 14 FR (4.7mm) x 3.5cm | In distribution |
| 35-1820 | Length 2 cm | In distribution |
| 35-1630 | Catheter Gauge 16 Fr | In distribution |
| 35-1645 | Length 4.5 cm | In distribution |
| 55-1420 | Catheter Gauge 14 Fr | In distribution |
| 55-2440 | Length 4 cm | In distribution |
| 55-1845 | Length 4.5 cm | In distribution |
| 35-2030 | 20 FR (6.7mm) X 3.0cm | In distribution |
| 55-1440 | Length 4 cm | In distribution |
| 35-1625 | 16 FR (5.3mm) X 2.5cm | In distribution |
| 35-2430 | Length 3 cm | In distribution |
| 55-1445 | Length 4.5 cm | In distribution |
| 35-2420 | 24 FR (8mm) X 2.0cm | In distribution |
| 35-1420 | Catheter Gauge 14 Fr | In distribution |
| 55-1245 | Length 4.5 cm | In distribution |
| 55-2425 | 24 FR (8mm) x 2.5cm | In distribution |
| 35-2015 | 20 FR (6.7mm) X 1.5cm | In distribution |
| 55-2435 | 24 FR (8mm) x 3.5cm | In distribution |
| 55-1220 | Catheter Gauge 12 Fr | In distribution |
| 35-1635 | 16 FR (5.3mm) X 3.5cm | In distribution |
| 35-2025 | Catheter Gauge 20 Fr | In distribution |
| 35-1825 | Catheter Gauge 18 Fr | In distribution |
| 35-1445 | Catheter Gauge 14 Fr | In distribution |
| 55-2430 | 24 FR (8mm) x 3.0cm | In distribution |
| 55-1425 | Catheter Gauge 14 Fr | In distribution |
| 55-2420 | Catheter Gauge 24 Fr | In distribution |
| 55-2045 | 20 FR (6.7mm) x 4.5cm | In distribution |
| 55-1830 | 18 FR (6mm) x 3.0cm | In distribution |
| 55-1215 | 12 FR (4mm) x 1.5 cm | In distribution |
| 35-2415 | Catheter Gauge 24 Fr | In distribution |
| 55-1645 | Catheter Gauge 16 Fr | In distribution |
| 55-1630 | Catheter Gauge 16 Fr | In distribution |
| 55-1635 | Catheter Gauge 16 Fr | In distribution |
| 55-1225 | Catheter Gauge 12 Fr | In distribution |
| 35-1830 | Catheter Gauge 18 Fr | In distribution |
| 35-1425 | 14 FR (4.7mm) X 2.5cm | In distribution |
| 35-1435 | Catheter Gauge 14 Fr | In distribution |
| 35-2040 | 20 FR (6.7mm) X 4.0cm | In distribution |
| 55-2415 | Catheter Gauge 24 Fr | In distribution |
| 35-1835 | 18 FR (6mm) X 3.5 cm | In distribution |
| 55-2030 | Catheter Gauge 20 Fr | In distribution |
| 55-1840 | Length 4 cm | In distribution |
| 55-1415 | 14 FR (4.7mm) x 1.5cm | In distribution |
| 35-1215 | Catheter Gauge 12 Fr | In distribution |
| 35-2410 | Length 1 cm | In distribution |
| 35-2045 | 20 FR (6.7mm) X 4.5cm | In distribution |
| 35-1220 | Catheter Gauge 12 Fr | In distribution |
| 55-1230 | Catheter Gauge 12 Fr | In distribution |
| 55-1810 | Length 1 cm | In distribution |
| 35-2425 | 24 FR (8mm) X 2.5cm | In distribution |
| 35-1845 | Length 4.5 cm | In distribution |
| 55-1210 | 12 Fr (4mm) x 1.0cm | In distribution |
| 55-1265 | 12 FR (4mm) x 6.5cm | In distribution |
| 55-1835 | Length 3.5 cm | In distribution |
| 35-2020 | 20 FR (6.7mm) X 2.0cm | In distribution |
| 35-1615 | Catheter Gauge 16 Fr | In distribution |
| 55-1240 | Catheter Gauge 12 Fr | In distribution |
| 55-1615 | 16 FR (5.3mm) x 1.5cm | In distribution |
| 55-1620 | 16 FR (5.3mm) x 2.0cm | In distribution |
| 35-1440 | 14 FR (4.7mm) X 4.0cm | In distribution |
| 35-1210 | Length 1 cm | In distribution |
| 35-1225 | 12 FR (4mm) X 2.5 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Avanos | Avanos Medical, Inc. | 1,169 |
| Halyard | Avanos Medical, Inc. | 1,004 |
| G-Jet® Transgastric-Jejunal Feeding Device | Applied Medical Technology, Inc. | 376 |
| MiniONE Balloon Button | Applied Medical Technology, Inc. | 373 |
| Mini ONE® Balloon Button | Applied Medical Technology, Inc. | 336 |
| Kangaroo | Cardinal Health | 326 |
| NutraGlide Nasal Feeding Tube | Applied Medical Technology, Inc. | 279 |
| AMT Mini™ Balloon Button | Applied Medical Technology, Inc. | 231 |
| Vygon | Vygon Corp. | 229 |
| NeoDevices, Inc. | Neodevices Inc | 123 |
| Kangaroo | Cardinal Health 200, LLC | 98 |
| MiniACE | Applied Medical Technology, Inc. | 93 |
Showing 12 of 457. All products under Tubes, Gastrointestinal (And Accessories)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K133599 | 2014-03-26 |
| K131532 | 2013-08-12 |
| K113351 | 2012-01-10 |
| K100365 | 2010-05-20 |
| K091637 | 2009-09-29 |
| K990127 | 1999-02-10 |
| K840656 | 1984-04-04 |
| K831328 | 1983-07-19 |
| K821906 | 1982-07-13 |
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.