MicroEZ Introducer
4.5F MicroEZ Microintroducer Safety Kit
13manufacturers in China registered for this device type
29catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (5), Beijing (3), Shanghai (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Tianjin Demax Medical Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| Beijing Demax Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Tianjin Ethylene Oxide Sterilization Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 4 |
| Shanghai Microport EP Medtech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
| Becton Dickinson Medical Devices Co., Ltd. Suzhou | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Cardiocycle Medical(Suzhou) Co., Ltd. | Suzhou | Jiangsu | Complaint-file establishment | 1 |
Showing 12 of 13. All 13 manufacturers in China registered for Introducer, Catheter
Record
| Listed by | Bard Access Systems, Inc., United States |
|---|---|
| FDA product code | DYB |
| Device type | Introducer, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1340 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-21 |
| Record revised | 2024-03-20 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 10 |
| Sizes | Catheter gauge 3.5 to 6 Fr; length 5 to 10 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0688945 | Catheter Gauge 4.5 Fr | In distribution |
| CK000744 | Length 10 cm | In distribution |
| 0928960 | Catheter Gauge 6 Fr | In distribution |
| 0678960 | Length 5 cm | In distribution |
| 0828935 | Catheter Gauge 3.5 Fr | In distribution |
| 0678950 | Catheter Gauge 5 Fr | In distribution |
| 0928950 | Catheter Gauge 5 Fr | In distribution |
| 0688935 | Length 5 cm | In distribution |
| 0828950 | Length 7 cm | In distribution |
| CK000742 | Catheter Gauge 5 Fr | In distribution |
| 0828960 | Length 7 cm | In distribution |
| 0128960 | Length 10 cm | In distribution |
| 0928945 | Catheter Gauge 4.5 Fr | In distribution |
| 0128950 | Catheter Gauge 5 Fr | In distribution |
| 0688950 | Catheter Gauge 5 Fr | In distribution |
| 0928935 | Length 7 cm | In distribution |
| CK000743 | Length 7 cm | In distribution |
| 0678945 | Catheter Gauge 4.5 Fr | In distribution |
| 0738945 | Length 5 cm | In distribution |
| 0228950 | Length 10 cm | In distribution |
| 0688960 | Catheter Gauge 6 Fr | In distribution |
| 0678935 | Catheter Gauge 3.5 Fr | In distribution |
| 0228960 | Catheter Gauge 6 Fr | In distribution |
| 0738950 | Length 5 cm | In distribution |
| 0738935 | Length 5 cm | In distribution |
| 0828945 | Catheter Gauge 4.5 Fr | In distribution |
| 0228945 | Length 10 cm | In distribution |
| 0128945 | Catheter Gauge 4.5 Fr | In distribution |
| 0738960 | Catheter Gauge 6 Fr | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Demax | Beijing Demax Medical Technology Co., Ltd. | 2,841 |
| Arrow | Teleflex Medical LLC | 1,036 |
| Prelude IDeal™ | Merit Medical Systems, Inc. | 294 |
| Fast-Cath™ | St. Jude Medical | 213 |
| Flexor | Cook Incorporated | 182 |
| Prelude Ease™ | Merit Medical Systems, Inc. | 176 |
| Performer | Cook Incorporated | 174 |
| VSI | Teleflex Medical LLC | 154 |
| Peel-Away | Cook Incorporated | 153 |
| OptiSeal™ | Greatbatch Medical | 127 |
| Brilliant | Lepu Medical Technology (Beijing) Co., Ltd. | 122 |
| Super Sheath | Togo Medikit Co., Ltd. | 122 |
Showing 12 of 439. All products under Introducer, Catheter
Recalls
2 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 | Closed |
|---|---|---|---|---|---|
| 2013-02-21 | Class II | Mixed-up of materials/components | Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 French Dual Lumen Catheters with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer Systems due to the wrong size introducer bein | 195 units. | 2014-01-03 |
| 2013-02-21 | Class II | Mixed-up of materials/components | Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 French Dual Lumen Catheters with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer Systems due to the wrong size introducer bein | 73 units | 2014-01-03 |
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.