Nurse Assist
60ML Prefilled Syringe
17manufacturers in China registered for this device type
12catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (5), Zhejiang (4), Guangdong (3). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Primecare Medical (Suzhou) Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 20 |
| Haiyan Kangyuan Medical Instrument Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 17 |
| Primecare Medical (Huzhou) Co., Ltd. | Hu Zhou | Zhejiang | Contract manufacturer | 9 |
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
| Well Lead Medical (Hainan) Co., Ltd. | Haikou | Hainan | Contract manufacturer | 3 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Hangzhou Primecare Medical Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Amsino Medical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 22 |
Showing 12 of 17. All 17 manufacturers in China registered for Catheter, Retention Type, Balloon
Record
| Listed by | Nurse Assist, LLC, United States |
|---|---|
| FDA product code | EZL |
| Device type | Catheter, Retention Type, Balloon |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Manufacturer |
| 510(k) | K030813 |
| Record published | 2016-09-24 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 6024 | 40 | In distribution | |
| 52332 | 400 | In distribution | |
| 57849 | 400 | In distribution | |
| PT00014226 | 400 | In distribution | |
| 52333 | 200 | In distribution | |
| 51617 | 200 | In distribution | |
| 57850 | 400 | In distribution | |
| PT00014224 | 400 | In distribution | |
| 1030A | 200 | In distribution | |
| 1010 | 400 | In distribution | |
| 51638 | 400 | In distribution | |
| 1030 | 200 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| All Silicone Foley Catheter | Well Lead Medical Co., Ltd. | 175 |
| Dover | Cardinal Health 200, LLC | 85 |
| Dover | Cardinal Health | 82 |
| Rusch | Teleflex Medical LLC | 79 |
| Porges Coloplast | Coloplast A/S | 74 |
| Medline | Medline Industries, Inc. | 72 |
| McKesson | Mckesson Medical-Surgical Inc. | 63 |
| TruCath | HR Pharmaceuticals Inc. | 59 |
| Folysil | Coloplast A/S | 47 |
| Sunmed | SunMed Group Holdings, LLC | 35 |
| Universa | Cook Incorporated | 31 |
| AMSure ® Hydrophilic Latex Foley Catheters | Amsino Medical Inc. | 31 |
Showing 12 of 135. All products under Catheter, Retention Type, Balloon
Recalls Naming This Product
25 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Nurse Assist, LLC | 510(k) number | 2023-11-06 | Class I | Process control | Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection. | 15,800 Cases | |
| Covidien | 510(k) number | 2016-01-22 | Class II | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria | 3000 | 2017-06-20 |
| Covidien | 510(k) number | 2016-01-22 | Class II | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria | 1800 | 2017-06-20 |
| Covidien | 510(k) number | 2016-01-22 | Class II | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria | 71430 | 2017-06-20 |
| Covidien | 510(k) number | 2016-01-22 | Class II | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria | 83400 | 2017-06-20 |
| Covidien | 510(k) number | 2016-01-22 | Class II | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria | 7200 | 2017-06-20 |
| Covidien | 510(k) number | 2016-01-22 | Class II | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria | 3600 | 2017-06-20 |
| Covidien | 510(k) number | 2016-01-22 | Class II | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria | 31200 | 2017-06-20 |
| Covidien | 510(k) number | 2016-01-22 | Class II | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria | 7200 | 2017-06-20 |
| Covidien | 510(k) number | 2016-01-22 | Class II | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria | 600 | 2017-06-20 |
| Covidien | 510(k) number | 2016-01-22 | Class II | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria | 11400 | 2017-06-20 |
| Covidien | 510(k) number | 2016-01-22 | Class II | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria | 7200 | 2017-06-20 |
| Covidien | 510(k) number | 2016-01-22 | Class II | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria | 600 | 2017-06-20 |
| Covidien | 510(k) number | 2016-01-22 | Class II | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria | 300 | 2017-06-20 |
| Covidien | 510(k) number | 2016-01-22 | Class II | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria | 4500 | 2017-06-20 |
| Covidien | 510(k) number | 2016-01-22 | Class II | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria | 16500 | 2017-06-20 |
| Covidien | 510(k) number | 2016-01-22 | Class II | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria | 1320 | 2017-06-20 |
| Covidien | 510(k) number | 2016-01-22 | Class II | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria | 5940 | 2017-06-20 |
| Covidien | 510(k) number | 2016-01-22 | Class II | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria | 95700 | 2017-06-20 |
| Covidien | 510(k) number | 2016-01-22 | Class II | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria | 13060 | 2017-06-20 |
| Covidien | 510(k) number | 2016-01-22 | Class II | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria | 25080 | 2017-06-20 |
| Covidien | 510(k) number | 2016-01-22 | Class II | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria | 1950 | 2017-06-20 |
| Covidien | 510(k) number | 2016-01-22 | Class II | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria | 9200 | 2017-06-20 |
| Covidien | 510(k) number | 2016-01-22 | Class II | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria | 1980 | 2017-06-20 |
| Covidien | 510(k) number | 2016-01-22 | Class II | Nonconforming Material/Component | Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria | 3280 | 2017-06-20 |
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.