Rusch
St. Bartholomew Catheter with 250cc Balloon
25manufacturers in China registered for this device type
9catalogue numbers in this listing
1510(k) clearance
2recalls on this 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 | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | KNT |
| Device type | Tubes, Gastrointestinal (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5980 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K973892 |
| Record published | 2016-09-16 |
| Record revised | 2022-09-28 (version 11) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep dry; Keep away from sunlight |
| Packaging | Carton of 20, box of 2, case of 10, box |
| Sizes | Catheter gauge 14 to 21 Fr |
| Distribution end date | 2018-09-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN004373 | Catheter Gauge 18 Fr | In distribution |
| IPN004371 | Catheter Gauge 16 Fr | In distribution |
| IPN004367 | Catheter Gauge 18 Fr | In distribution |
| IPN004368 | Catheter Gauge 21 Fr | In distribution |
| IPN004372 | Catheter Gauge 18 Fr | In distribution |
| IPN004370 | Catheter Gauge 14 Fr | In distribution |
| IPN004366 | Catheter Gauge 16 Fr | In distribution |
| IPN050004 | Withdrawn | |
| IPN051151 | Withdrawn |
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 |
| Corflo cuBBy Lpgd | Corpak Medsystems | 98 |
| Kangaroo | Cardinal Health 200, LLC | 98 |
Showing 12 of 457. All products under Tubes, Gastrointestinal (And Accessories)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K043258 | 2004-12-16 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Teleflex Medical LLC | 510(k) number | 2014-03-04 | Class II | Other | Sterility of the product cannot be guaranteed. | 117,801 ea. | 2016-01-28 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-03-15 | Class II | Employee error | These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions. | 200 units | 2020-10-05 |
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.