EndoVive™ One Step Button™
Low Profile Percutaneous Endoscopic Gastrostomy Kit
17manufacturers in China registered for this device type
14catalogue numbers in this listing
2510(k) clearances naming this product code
4recalls on this code
Who Else Makes It
Concentrated in Jiangsu (8), Zhejiang (4), Guangdong (2). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| 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 |
| Mcreat ( Guangzhou ) BIO-Tech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 14 |
| Jiangsu Kangjin Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 13 |
| Ucomfor Scientific Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 13 |
| Primecare Medical (Huzhou) Co., Ltd. | Hu Zhou | Zhejiang | Contract manufacturer | 9 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
Showing 12 of 17. All 17 manufacturers in China registered for Gastrointestinal Tubes With Enteral Specific Connectors
Record
| Listed by | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | PIF |
| Device type | Gastrointestinal Tubes With Enteral Specific Connectors |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5980 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2017-10-30 |
| Record revised | 2022-06-10 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M00509740 | 1.7 cm Length | In distribution |
| M00509620 | 8.0 mm Diameter | In distribution |
| M00509700 | 1.7 cm Length | In distribution |
| M00509610 | 4.4 cm Length | In distribution |
| M00509710 | 2.4 cm Length | In distribution |
| M00509730 | 6.0 mm Diameter | In distribution |
| M00509580 | 24 F Diameter | In distribution |
| M00509630 | 24 F Diameter | In distribution |
| M00509600 | 8.0 mm Diameter | In distribution |
| M00509690 | 1.2 cm Length | In distribution |
| M00509590 | 2.4 cm Length | In distribution |
| M00509680 | 8.0 mm Diameter | In distribution |
| M00509720 | 3.4 cm Length | In distribution |
| M00509750 | 2.4 cm Length | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Micro G-Jet® | Applied Medical Technology, Inc. | 52 |
| Nutricare | Gbuk Group Limited | 44 |
| Enteral | Gbuk Group Limited | 42 |
| Traditional G-Jet® | Applied Medical Technology, Inc. | 37 |
| Medline | Medline Industries, Inc. | 22 |
| Kangaroo | Cardinal Health 200, LLC | 17 |
| Aquarius | Degania Silicone, Ltd. | 16 |
| AMT Mini ONE® Extension Set | Applied Medical Technology, Inc. | 16 |
| Vesco Medical Pediatric Nasogastric Feeding Tubes | Cair LGL | 13 |
| Kangaroo | Cardinal Health | 13 |
| Vesco Medical Nasogastric Feeding Tubes | Cair LGL | 12 |
| Cardinal Health | Cardinal Health 200, LLC | 11 |
Showing 12 of 116. All products under Gastrointestinal Tubes With Enteral Specific Connectors
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K161003 | 2016-06-17 |
| K150679 | 2015-05-29 |
Recalls
4 of these are 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 |
|---|---|---|---|---|
| 2026-02-10 | Class II | Process control | Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This component is placed outside | 806 units |
| 2024-02-20 | Class II | Process design | Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events whi | 2726 units |
| 2024-02-20 | Class II | Process design | Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events whi | 572 units |
| 2023-12-19 | Class II | Under Investigation by firm | Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replacement button, but are labeled as being for a 28F. Use of defective product may lead to undersizing the button, which may cause embedding with e | 0 US; 74 OUS |
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.